Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Class I - Dangerous
Tritanium Patella Inserter Instrument fracture during implantation. .
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Blue Belt Technologies MN
Class I - Dangerous
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Blue Belt Technologies MN
Class I - Dangerous
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Class I - Dangerous
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.
Class I - Dangerous
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
Class I - Dangerous
During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort
Class I - Dangerous
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Class I - Dangerous
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
Class I - Dangerous
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.