Device product
Z1 Femoral Hip System, Product Number 611777612
Z-1329-2025
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 96348
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-1329-2025
Official wording
Reason: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Code information: UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
design issue