Recall Z-1951-2021
Smith & Nephew, Inc. · initiated May 19, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot 20HM17607
Reason for recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1951-2021
- Initiated
- May 19, 2021
- Terminated
- April 14, 2023
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN