Recall Z-2519-2023 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer, Inc.
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
| Date | Sep 7, 2023 (initiated Jul 26, 2023) |
| Status | Open, Classified |
| Reason | The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. |
| Root cause | Mixed-up of materials/components |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 7/26/23 was sent to customers. 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 customers with the recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of |
| Quantity | 24 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer, Inc., Jul 9, 2020 |