FDA Medical devices recall ·
Z1 Femoral Hip System, Product Number 611777612 recall
- Recall number
- Z-1329-2025
- Date
- (initiated February 12, 2025)
- Company / brand
- Zimmer, Inc.
1800 W Center St, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Z1 Femoral Hip System, Product Number 611777612
Why was it recalled?
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1329-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.