Recall Z-1792-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer GmbH
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
| Date | May 7, 2021 |
| Status | Terminated |
| Reason | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree |
| Root cause | Process design |
| Action | Zimmer Biomet Zimmer Biomet notifed distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory notified via on 5/11/21. Letter states reason for recall, health risk and action to take: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete A |
| Quantity | 8 units |
| Distribution | CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Zimmer GmbH, Oct 28, 2009 |