Recall Z-1036-2023 ยท HSB Rod, Fixation, Intramedullary And Accessories
Biomet, Inc.
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
| Date | Jan 27, 2023 (initiated Nov 29, 2022) |
| Status | Open, Classified |
| Reason | Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement |
| Root cause | Process control |
| Action | ****UPDATE***Phase II Zimmer Biomet issued Urgent Medical Device Recall Letter (Removal) on March 7, via FedEx to the Distributor and Risk Manager. Letter states health risk and action to take: 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. If the product has been further distributed, provide yo |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of CA, KY, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042409 | MODULAR ARTHRODESIS NAIL Biomet, Inc., Dec 2, 2004 |