Recall Z-0304-2018 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
| Date | Jun 5, 2017 |
| Status | Terminated |
| Reason | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. |
| Root cause | Labeling False and Misleading |
| Action | On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the Certificate of Acknowledgement and return a digital copy to corp |
| Distribution | Nationwide in US; Internationally Argentina, Netherlands & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020381 | EXPANDABLE KNEE Biomet Orthopedics, Inc., May 6, 2002 |