Fixone Hybrid Anchor
FDA device recall Z-1166-2026 · posted 2026-01-26 · Open, Classified
Recall details
- Recalling firm
- Aju Pharm Co., Ltd.
- Reason for recall
- Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MAI
- Quantity affected
- 233 units
- Distribution
- US Nationwide distribution in the states of CA & PR.
- Date initiated
- 2025-12-17
- Date posted
- 2026-01-26
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Fixone Meniscal Repair (K233601) | Aju Pharm Co., Ltd. | 2024-08-02 |
| Fixone Biocomposite Anchor (K230892) | Aju Pharm Co., Ltd. | 2023-06-09 |
| Fixone All Suture Anchor (K222423) | Aju Pharm Co., Ltd. | 2023-03-23 |
| Fixone hybrid knotless anchor (K203523) | Aju Pharm Co., Ltd. | 2021-12-25 |
| Fixone Biocomposite Interference Screw (K193497) | Aju Pharm Co., Ltd. | 2021-01-05 |