Device product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Z-1039-2025
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 96090
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 155 units
- Official record key
device-enforcement:Z-1039-2025
Official wording
Reason: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Code information: UDI-DI: 00889024635746; Lot Numbers:66782843 66782840 66873137
Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.
Derived failure modes
-
Unknown
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.