Z-1329-2025 Class II Ongoing
FDA device recall Z-1329-2025 was initiated by Zimmer, Inc. on February 12, 2025 and is designated Class II. Reason for recall: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. The recall status is ongoing. Affected quantity: 35 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2025
- Initiation Date
- February 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
Z1 Femoral Hip System, Product Number 611777612
Reason for Recall
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277