DePuy Orthopaedics, Inc.
6 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for DePuy Orthopaedics, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-10FDA-DeviceClass IIATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
- 2023-03-29FDA-DeviceClass IIAttune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-29FDA-DeviceClass IIAttune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-29FDA-DeviceClass IIAttune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-29FDA-DeviceClass IIAttune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-29FDA-DeviceClass IIAttune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
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