Device product
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Z-1011-2018
Product summary
- Event
- Event 79250
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-1011-2018
Official wording
Reason: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
Code information: Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
Distribution pattern: US Distribution to states of: FL, WI, MD, MO, and MI.
Derived failure modes
-
Unknown
The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.