Recall Z-0300-2018 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Zimmer Biomet, Inc.
ECHO POR FMRL NC 9X125, model # 192009
| 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
| K070274 | ECHO BI-METRIC PRESS-FIT STEMS Biomet Manufacturing Corp, Apr 3, 2007 |