FDA-Device2026-02-04Class IIPROCESSING DEFECT
Aju Pharm Fixone Hybrid Anchor recalled for device failure and breakage
What this means
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
The agency's original wording
Hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Intended for
Adults
Illnesses reported
None reported
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-1166-2026Want us to check the next one for you?
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