FDA Enforcement
Class II
Ongoing
Fixone Biocomposite Anchor
Recall: Z-1167-2026
·
Reported February 4, 2026
Enforcement
- Recall Number
- Z-1167-2026
- Event ID
- 98312
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aju Pharm Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 4, 2026
- Initiation Date
- December 17, 2025
- Classification Date
- January 26, 2026
- Address
- Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, N/A, Korea (the Republic of)
Description
Fixone Biocomposite Anchor
Reason
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Code Info
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
Distribution
US Nationwide distribution in the states of CA & PR.
Quantity
1,088 units