FDA recall Z-1329-2025
Zimmer, Inc. · Class II · device
Product
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
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-02-12
- Report date
- 2025-03-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Warsaw, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1329-2025