Recall Z-3246-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures
| Date | Jul 30, 2018 |
| Status | Terminated |
| Reason | The item is labeled as an 8.3mm, but it is actually a 12 mm. |
| Root cause | Mixed-up of materials/components |
| Action | On 7/30/18, Urgent Medical Device Recall notification letters were distributed to customers. Distributors were instructed to do the following: 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 and surgeons within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a R |
| Quantity | 1 unit |
| Distribution | The product was not distributed in the United States. The product was distributed in the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082770 | ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL Zimmer, Inc., Dec 11, 2008 |