125 results
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29ms
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Sources: EU EUDAMED, US FDA
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting).
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code EMM·April 16, 2008
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
"***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
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
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
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
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KQC·July 30, 2007
Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
FDA Recall
Terminated
·EMD Chemicals Inc.·Product code KQC·April 4, 2011
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
FDA Recall
Terminated
·EMD Chemicals Inc·Product code J·August 17, 2006
Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code LCH·December 13, 2002
EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code DNN·March 27, 2008
Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code HZT·June 2, 2008
Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95
FDA Recall
Terminated
·EMD Chemicals Inc·Product code LCH·December 13, 2002
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
FDA Recall
Terminated
·EMD Chemicals Inc·Product code J·August 17, 2006
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KKS·July 25, 2006