FDA-Device2026-02-04Class IIPROCESSING DEFECT
Genesis Knotless Anchor recalled for device failure including breakage and pull out
What this means
Aju Pharm Co., Ltd. is recalling Genesis Knotless Anchor surgical devices due to reports of device failure. The anchor can break, bend, pull out of tissue, the suture can break, or the packaging can break during handling or use.
- Stop using Genesis Knotless Anchor models 10KPN4751 and 10KPN5501 immediately
- Contact Aju Pharm Co., Ltd. or your surgical supplier for instructions on return or replacement
- Alert your healthcare facility or surgeon if you have this device in 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
1,163 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
Genesis Knotless Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1170-2026Want us to check the next one for you?
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