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.
This recall has been terminated (originally issued May 19, 2021).
- Company
- Smith & Nephew Inc
- Recall Initiated
- May 19, 2021
- Terminated
- April 14, 2023
- Recall Number
- Z-1951-2021
- Quantity
- 5 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Distribution
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Lot / Code Info
Lot 20HM17607
Root 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.
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