FDA-Device2026-02-04Class II
AlternatiV+ Screw-In Anchor
Aju Pharm Co., Ltd.
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
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-1173-2026Don't want to check this manually?
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