Device 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.
Z-1951-2021
Product summary
- Event
- Event 88010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1951-2021
Official wording
Reason: The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Code information: Lot 20HM17607
Distribution pattern: US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Derived failure modes
-
Manufacturing or process control
manufacturing process error