Recall Z-0212-2026 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
| Date | Oct 17, 2025 (initiated Sep 23, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet issued an URGENT MEDICAL DEVICE RECALL notice to its consignees (Distributors and Risk Managers-separate notices) on 09/23/2025 via FedEx 2nd day. The notice explained the issue, risk, and requested the consignee (distributors) identify and quarantine the affected product and immediately return all affected product from your distributorship and from affected hospitals within your territory, review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall, Identify whether th |
| Quantity | 98 units |
| Distribution | Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO Biomet Manufacturing Corp, Aug 1, 2013 |