DePuy Orthopaedics, Inc. Recall 91752
Description: Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
DePuy Orthopaedics, Inc. Recall 91752 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1263-2023 |
| Event ID | 91752 |
| Event Description | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand |
| Quantity | 7 units |
| Recall Reason | 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. |
| Device Classification | 20230329 |
| Device Code Info | GTIN: 10603295491095; Lot: JP6452 |
| Center Classification Date | 20230317 |
| Recall Initiation Date | 20230215 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Letter |
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