Reported Feb 4, 2026 · Ongoing
Fixone Biocomposite Anchor
Aju Pharm Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aju Pharm Co., Ltd. · Room 201, Room 207, Bl A · Seongnam, N/A · N/A
Is this the product you have?
- Fixone Biocomposite Anchor
- Lot codes and dates
Model No. BAB-55003chBAN-55003bSAB-30002eAll UDI CodesAll Lots
- Amount recalled
- 1,088 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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