Aju Pharm Co., Ltd. recalls Genesis Dual Thread Screw-In 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 ajumedi@ajupharm.co.kr.

• FDA enforcement recordOfficial FDA database entry for Z-1169-2026
• FDA 510(k) clearance · K193497The device's official FDA premarket clearance record
• FDA 510(k) clearance · K203523The device's official FDA premarket clearance record
• FDA 510(k) clearance · K222423The device's official FDA premarket clearance record
• FDA 510(k) clearance · K230892The device's official FDA premarket clearance record
• FDA 510(k) clearance · K233601The device's official FDA premarket clearance record
• FDA device classification · MAIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Aju Pharm Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.