DePuy Orthopaedics, Inc. Recall 89454
Description: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
DePuy Orthopaedics, Inc. Recall 89454 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0631-2022 |
| Event ID | 89454 |
| Event Description | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of TN, TX. |
| Quantity | 6 units |
| Recall Reason | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. |
| Device Classification | 20220216 |
| Device Code Info | Lots: JH9651, JH9649 GTIN: 10603295383178 |
| Center Classification Date | 20220209 |
| Recall Initiation Date | 20220105 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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