Recall Z-1951-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
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.
| Date | May 19, 2021 |
| Status | Terminated |
| Reason | The device components experienced a manufacturing process error that resulted in surface damage from product handling. |
| Root cause | Nonconforming Material/Component |
| Action | On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc., Feb 18, 2005 |