FDAHealthDecember 17, 2025
Aju Pharm Co., Ltd. — Fixone Biocomposite Anchor
⚠️ Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 17, 2025
US Nationwide distribution in the states of CA & PR.
What's affected?
- Product
- Fixone Biocomposite Anchor
- Brand
- Aju Pharm Co., Ltd.
- Lot code
- s
Additional details
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,088 units.
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