FDA-Device2026-02-04Class IIPROCESSING DEFECT
Aju Pharm Genesis Push-In Suture Anchor recalled for device failure risk
OTHERNationwide distribution
Stop using Aju Pharm suture anchors
Aju Pharm's Genesis Push-In Suture Anchor has been recalled due to reports of device failure during use, including the anchor breaking, bending, or pulling out, as well as suture breakage. About 200 units were distributed nationwide in California and Puerto Rico.
- Stop using the Genesis Push-In Suture Anchor (Model No. 10S30002).
- Contact your healthcare provider immediately if you have had this device implanted.
- Do not discard the device; return it to your healthcare provider or manufacturer.
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
200 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Genesis Push-In Suture Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1171-2026Don't want to check this manually?
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