Genesis Push-In Suture Anchor
Recall
- Recall Number
- Z-1171-2026
- Event Number
- 98312
- Firm
- Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)
- FEI Number
- 3014232239
- Product Code
- MAI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 17, 2025
- Posted
- January 26, 2026
Description
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
An URGENT MEDICAL DEVICE RECALL notice dated 12/17/25 was mailed to consignees. The notification instructs consignees to discontinue use of affected devices, segregate affected devices, and return the product to Aju Pharm Medical or the authorized distributor. If product was further distributed the recall notification is to be forwarded for their awareness. Aju Pharm states that no additional action is required for patients who have already undergone surgery using affected devices. Consignees with any questions should contact +82-02-2630-0641 by phone or [email protected].
US Nationwide distribution in the states of CA & PR.
200 units