Recall Z-2179-2024 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet, Inc.
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
| Date | Jun 25, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet issued Urgent Medical Device Recall Letter on 5/17/24 to Distributors and End-Users via FedEx and email. Letter states reason for recall, health risk and action to take: 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 the product has been further distributed, provide your custome |
| Quantity | 12 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT Biomet, Inc., Sep 29, 2005 |