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Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)

FDA Recall
Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM

FDA Recall
Open, Classified ·Cerenovus Inc·Product code HCG·October 2, 2025

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

FDA Recall
Terminated ·Conformis, Inc.·Product code LPH·October 16, 2018

BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.

FDA Recall
Terminated ·Biomet 3i, Inc.·Product code NHA·February 6, 2008

Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·December 17, 2013

Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HDQ·February 23, 2024

The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Prestige Coil Model Numbers and Product description: PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack PRES0930H

FDA Recall
Open, Classified ·BALT USA, LLC·Product code KRD·January 3, 2024

Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·October 26, 2012

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P

FDA Recall
Open, Classified ·NuVasive Specialized Orthopedics, Inc.·Product code HSB·October 29, 2021

Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti

FDA Recall
Open, Classified ·BALT USA, LLC·Product code HCG·January 3, 2024

PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·August 7, 2014

Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·June 10, 2013

NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra

FDA Recall
Open, Classified ·Nuvasive Specialized Orthopedics Inc·Product code HSB·February 12, 2021

PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·August 7, 2014

Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·June 10, 2013

"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement

FDA Recall
Terminated ·Endotec, Inc.·Product code NRA·September 21, 2011

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

FDA Recall
Open, Classified ·Product code NLH·December 22, 2025

Recreo Hair Growth Laser Comb

FDA Recall
Open, Classified ·OMM Imports, Inc. dba Zero Gravity·Product code OAP·September 1, 2022

Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long, 26mm, +6mm Femoral head, X-long, 26mm, +9mm Femoral head, 28mm, -3mm Femoral head, 28mm, +0mm Femoral head, 28mm, +5mm Femoral head, 28mm, +10mm Femoral head, 32mm, -3mm Femoral head, 32mm, +0mm Femoral head, 32mm, +5mm Femoral head, 32mm, +10mm Femoral head, 36mm, -3mm Femoral head, 36mm, +0mm Femoral head, 36mm, +5mm Femoral head, 36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.

FDA Recall
Terminated ·Orthopedic Alliance LLC·Product code LPH·February 20, 2013

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

FDA Recall
Open, Classified ·Tornier, Inc·Product code KWS·June 12, 2023