Recall Z-1008-2018 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Biomet, Inc.
36MM COCR MODULAR HD -6MM
| Date | Sep 15, 2017 |
| Status | Terminated |
| Reason | One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field. |
| Root cause | Error in labeling |
| Action | Foreign risk managers were emailed notification of recall with the following instructions: 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. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do no |
| Quantity | 23 |
| Distribution | Outside USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS Biomet, Inc., Aug 21, 2003 |