FDA-Device2026-02-04Class IIPROCESSING DEFECT
Aju Pharm Fixone Hybrid Anchor recalled for device failure and breakage
OTHERNationwide distribution
Stop using Aju Pharm Fixone Hybrid Anchor
Aju Pharm's Fixone Hybrid Anchor, a surgical device, has been recalled due to reports of device failure. Problems include the anchor breaking, bending, or pulling out during use, as well as suture breakage and packaging damage. This affects 233 units distributed in California and Puerto Rico.
- Stop using the affected Fixone Hybrid Anchor devices immediately
- Check your device model number: KAPN-47501nc, KAPN-55001c, KAPN-55001na, or KAPN-55001nc
- Contact your healthcare provider or surgeon if you have questions about your device
- Report any problems with this device to the FDA MedWatch program
Hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Sold states
US Nationwide distribution in the states of CA & PR.
Affected count
233 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Fixone Hybrid Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1166-2026Don't want to check this manually?
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