Recall Z-1951-2021— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2021-05-19, terminated 2023-04-14. It names one FDA 510(k) clearance: K043440. 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.. Reason: The device components experienced a manufacturing process error that resulted in surface damage from product handling..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-19
- Terminated
- 2023-04-14
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.