FDA-Device2026-02-04Class IIPROCESSING DEFECT
Aju Pharm Fixone Biocomposite Anchor recalled for device failure and breakage
What this means
Aju Pharm's Fixone Biocomposite Anchor has been recalled due to reports of device failure, including anchor breakage, bending, pulling out, suture breakage, and packaging damage. The recall affects 1,088 units distributed in California and Puerto Rico. No injuries have been reported to date.
- Stop using the Fixone Biocomposite Anchor immediately if you have one
- Contact your healthcare provider or surgeon about replacement or alternative treatment
- Check the model number on your device: BAB-55003ch, BAN-55003b, or SAB-30002e
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
1,088 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Fixone Biocomposite Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2026Want us to check the next one for you?
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