Recall Z-1167-2026 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Aju Pharm Co., Ltd.
Fixone Biocomposite Anchor
| Date | Jan 26, 2026 (initiated Dec 17, 2025) |
| Status | Open, Classified |
| Reason | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1,088 units |
| Distribution | US Nationwide distribution in the states of CA & PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193497 | Fixone Biocomposite Interference Screw Aju Pharm Co., Ltd., Jan 5, 2021 |
| K203523 | Fixone hybrid knotless anchor Aju Pharm Co., Ltd., Dec 25, 2021 |
| K222423 | Fixone All Suture Anchor Aju Pharm Co., Ltd., Mar 23, 2023 |
| K230892 | Fixone Biocomposite Anchor Aju Pharm Co., Ltd., Jun 9, 2023 |
| K233601 | Fixone Meniscal Repair Aju Pharm Co., Ltd., Aug 2, 2024 |