Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor
- Recall date
- December 17, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1166-2026
- FDA classification
- Class II
- Brand / firm
- Aju Pharm Co., Ltd.
- Sold / distributed
- US Nationwide distribution in the states of CA & PR.
Why it was recalled
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fixone Hybrid Anchor
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