Device product
Total Knee Pack - Surgical Kit
Z-0864-2022
Product summary
- Event
- Event 89671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 76 units
- Official record key
device-enforcement:Z-0864-2022
Official wording
Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information: SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Distribution pattern: US Nationwide distribution in the states of IN, TX, and PA.
Derived failure modes
-
Sterility assurance
bag may be perforated or torn, which may result in a breach in the sterility