Device product
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Z-1904-2020
Product summary
- Event
- Event 85157
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-1904-2020
Official wording
Reason: The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Code information: Lot Number: A204324
Distribution pattern: US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Derived failure modes
-
Manufacturing or process control
manufacturing defect