Z-1167-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,088 units
Product Description
Fixone Biocomposite Anchor
Reason for Recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Distribution Pattern
US Nationwide distribution in the states of CA & PR.
Code Information
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.