Recall archive / FDA device enforcement
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint ... — FDA record Z-0212-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
- Reason
- There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- Classification
- Class II
- Recalling firm
- Biomet, Inc.
- Quantity
- 98 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0212-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (01)00880304478404(17)290130(10)0002587666; Lot Number 0002587666 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Sep 23, 2025
- Center classification date
- Oct 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.