Smith & Nephew, Inc. Recall 92286
Description: Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
Smith & Nephew, Inc. Recall 92286 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1671-2023 |
| Event ID | 92286 |
| Event Description | Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 1596 units |
| Recall Reason | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision. |
| Device Classification | 20230607 |
| Device Code Info | a) REF 1-10011-100, UDI/DI 00885556873083; b) REF 1-10011-200, UDI/DI 00885556873090; c) REF 1-10011-300, UDI/DI 00885556873106; ALL BATCHES |
| Center Classification Date | 20230531 |
| Recall Initiation Date | 20230502 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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