163 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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- Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless Steel 5.5mm x 12.0mm x 0.4mm Ref. 5023-160 Lot 123353 - Hall MicroChoice, Oscillating Saw Blade, Fine, Flat, Stainless Steel 5.5mm x 18.5mm x 0.4mm Ref. 5023-162 Lot 123353 - Hall MicroChoice, Sagittal Saw Blade, Fine 4.5mm x 25.5mm x 0.4mm Ref. 5023-139 Lot 122454 - Hall MicroChoice, Sagittal Saw Blade, Stainless Steel 9.5mm x 25.5mm x 0.4mm Ref. 5023-138 Lot 122454, 123353 - Large Sagittal Saw Blade 25mm x 89.5mm x 0.89mm Ref. 2108-102 Lot 122490 - Micro Choice Oscillating Saw Blade 5.5mm x 18.5mm x 0.40mm Ref. KM-3000 Lot 122440 - Micro Oscillating and Sagittal Saw Blade 9.0mm x 25mm x 0.51mm Ref. 2296-33-521 Lot 122609, 122429 - Oscillating and Sagittal Saw Blade 9.0mm x 31mm x 0.51mm Ref. 2296-33-225 Lot 122347 - Oscillating Sagittal Blade 9mm x 31mm x .38mm Ref. 2296-3-525 Lot 123263 - Oscillating Saw Blade 9.0mm x 25.0mm x .38mm Ref. SP-511 Lot 122631 - Oscillating Saw Blade 9mm x 25mm x .38mm Ref. 2296-3-511 Lot 122447 - Reciprocating Saw Blade, Double Sided Fixed Point Travel: 3.56mm 70mm x 12.5mm x 0.64mm Ref. 227-96-275 Lot 122490 - Round Fast Cutting Stainless Steel Bur, 8 Flute 4.8mm Ref. 1608-6-139 Lot 122447 - Sagittal Saw Blade 4.5mm x 25.4mm Ref. KM-3102 Lot 122465 - Small Oscillating Blade 9.0mm x 31.0mm x .4mm Ref. 2296-3-125 Lot 122447 - Small Oscillating Saw Blade 5.5mm x 11.5mm x 0.38mm Ref. 2296-3-410 Lot 122429 - Small Oscillating Saw Blade 5.5mm x 18.0mm x 0.4mm Ref. 2296-3-212 Lot 122511 - Small Oscillating Saw Blade 5.5mm x 18mm x 0.38mm Ref. 2296-3-412 Lot 122447 - Small Oscillating Saw Blade 7mm x 18.5mm x 0.38mm Ref. 2296-3-114 Lot 122429, 122511 - Small Oscillating Saw Blade 9.0mm x 31mm x 0.4mm Ref. 2296-3-225 Lot 122590, 122447 - Small Sagittal Saw Blade, Fine Tooth 9.5mm x 25.5mm x 0.4mm Ref. ZS-338 Lot 122647 - System 4 & System 2000 Sagittal Saw Blade 12.5mm x 81.5mm x 1.19mm Ref. 2108-152 Lot 122490 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 1.27mm x 11mm x 90mm Ref. 4111-127-090 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 18mm x 75mm x 0.89mm Ref. 4118-089-075 Lot 123263 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual Cut 25mm x 90mm x 1.27mm Ref. 4125-127-090 Lot 122347 - System 4, System 2000 & EHD Sagittal Saw Blade, Dual-Cut 18mm x 90mm x 1.35mm Ref. 4118-135-090 Lot 122347 Surgical instrument motors and accessories/attachments
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GFA·May 3, 2013
Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GFA·May 21, 2012
Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
FDA Recall
Terminated
·Synvasive Technology Inc·Product code GFA·December 8, 2015
Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GFA·February 14, 2008
Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
FDA Recall
Terminated
·Biomet, Inc.·Product code GFA·July 18, 2008
Exact Calcar Planer Rasp Style Blade, 50mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473798. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
FDA Recall
Terminated
·Biomet, Inc.·Product code GFA·July 18, 2008
Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
FDA Recall
Terminated
·Biomet, Inc.·Product code GFA·July 18, 2008
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
FDA Recall
Terminated
·Synvasive Technology Inc·Product code GFA·April 2, 2013
Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code GFA·June 13, 2011
Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code GFA·October 20, 2010
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code GFA·October 14, 2015
Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue.
FDA Recall
Terminated
·Sterilmed Inc·Product code GFA·August 8, 2008
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
FDA Recall
Terminated
·Synvasive Technology Inc·Product code GFA·July 27, 2018
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code GFA·March 19, 2019
Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
FDA Recall
Terminated
·Biomet, Inc.·Product code GFA·July 18, 2008
GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GFA·August 5, 2010
***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987. Soft Tissue resection and removal.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code GFA·November 12, 2009
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
FDA Enforcement
Class II
·Terminated·Agfa N.V.·August 7, 2019
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications
FDA Enforcement
Class II
·Terminated·Agfa N.V.·June 10, 2020