Smith & Nephew, Inc. Recall 88010
Description: LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Smith & Nephew, Inc. Recall 88010 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1951-2021 |
| Event ID | 88010 |
| Event Description | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution. |
| Quantity | 5 units |
| Recall Reason | The device components experienced a manufacturing process error that resulted in surface damage from product handling. |
| Device Classification | 20210630 |
| Device Code Info | Lot 20HM17607 |
| Center Classification Date | 20210624 |
| Recall Initiation Date | 20210519 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Letter |
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