Fixone Biocomposite Anchor
Pending LLM rewrite. Source: FDA_DEVICE Z-1167-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
The recalled product
- Product
- Fixone Biocomposite Anchor
- Manufacturer
- Aju Pharm Co., Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No. BAB-55003ch
- BAN-55003b
- SAB-30002e
- All UDI Codes
- All Lots.
Distribution
Distributed nationwide across the United States.
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