FDA-Device2026-02-04Class IIPROCESSING DEFECT
Genesis Dual Thread Screw-In Anchor recalled for device failure and breakage risk
What this means
Aju Pharm Co., Ltd. is recalling Genesis Dual Thread Screw-In Anchor devices (Models 10N47502 and 10N55002) due to reports of failure during use. The anchor may break, bend, pull out, or cause the suture to break.
- Stop using the device immediately if you have one
- Contact your healthcare provider or Aju Pharm Co., Ltd. for guidance on replacement or alternatives
- Return the device to your supplier or manufacturer if instructed
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
400 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Genesis Dual Thread Screw-In Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2026Want us to check the next one for you?
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