FDA-Device2026-02-04Class IIPROCESSING DEFECT
Aju Pharm AlternatiV+ Screw-In Anchor recalled for device failure risk
What this means
Aju Pharm's AlternatiV+ Screw-In Anchor has been recalled due to reports of device failure. The anchor may break, bend, pull out, or the suture may break during use. Approximately 416 units were distributed in California and Puerto Rico.
- Stop using AlternatiV+ Screw-In Anchors (Model No. 20BN4753 or 20BN5503)
- Contact your healthcare provider or surgical facility if you received this device
- Do not use remaining inventory
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
416 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
AlternatiV+ Screw-In Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2026Want us to check the next one for you?
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