Aju Pharm Co., Ltd. recalls Fixone Biocomposite Anchor
- Recalling company
- Aju Pharm Co., Ltd.
- Product
- Fixone Biocomposite Anchor
- Reason
- Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 17, 2025
- Reported
- Feb 4, 2026
- Distribution
- US Nationwide distribution in the states of CA & PR.
- Status
- Ongoing
- Quantity
- 1,088 units
- Lot / codes
- Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
- Company location
- Seongnam, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1167-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1167-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.