Device product
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Z-0674-2018
Product summary
- Event
- Event 79161
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0674-2018
Official wording
Reason: Knee implant components (tibial bearings) are labeled with the incorrect size.
Code information: Lot Number: 473290, Exp. Date 5/19/2022
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
Derived failure modes
-
Unknown
Knee implant components (tibial bearings) are labeled with the incorrect size.