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Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor
Recalled February 4, 2026 · FDA recall Z-1166-2026 · Aju Pharm
Hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. · FDA Class II
Units
233 units
Sold at
US Nationwide distribution in the states of CA & PR.
Description
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Product
Fixone Hybrid Anchor
Manufacturer(s)
Aju Pharm Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →