Recall Z-1329-2025 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer, Inc.
Z1 Femoral Hip System, Product Number 611777612
| Date | Mar 24, 2025 (initiated Feb 12, 2025) |
| Status | Open, Classified |
| Reason | There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification dated 2/12/25 was sent to customers. Our records indicate that you may have received one or more of the affected products. The affected units were distributed between September 2024 and January 2025. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If |
| Quantity | 35 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233476 | Z1 Hip System Orchard Medical Development, Feb 8, 2024 |