Device product
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Z-0212-2026
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 97670
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 98 units
- Official record key
device-enforcement:Z-0212-2026
Official wording
Reason: There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Code information: UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop