FDA-Device2026-02-04Class IIPROCESSING DEFECT
Genesis Screw-In Anchor recalled for device failure and breakage risk
OTHERNationwide distribution
Stop using Genesis Screw-In Anchor devices
Aju Pharm Co., Ltd. is recalling Genesis Screw-In Anchor devices due to reports of failure, including anchor breakage, bending, pull-out, suture breakage, and packaging damage. The recall affects models 10B45003, 10B55003, and 10B65003 distributed nationwide in California and Puerto Rico.
- Stop using affected Genesis Screw-In Anchor devices immediately
- Contact your healthcare provider or surgeon about replacement or alternative options
- Do not use any affected units, regardless of lot number or UDI code
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
600 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Genesis Screw-In Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2026Don't want to check this manually?
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