Recall Z-1522-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
| Date | Apr 3, 2018 |
| Status | Terminated |
| Reason | There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar. |
| Root cause | Nonconforming Material/Component |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letters to their affected customers. The letters identified the affected product, problem and the actions to be taken. Distributor 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. For each return, complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.Pos |
| Quantity | 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned |
| Distribution | The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042409 | MODULAR ARTHRODESIS NAIL Biomet, Inc., Dec 2, 2004 |