Device product
Anterior Hip Pack - Surgical Kit
Z-0865-2022
Product summary
- Event
- Event 89671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0865-2022
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 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943
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