Recall Z-1166-2026

Reason for recall

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

FDA-determined cause: Nonconforming Material/Component

Action taken

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 ajumedi@ajupharm.co.kr.