Recall Z-1166-2026— Aju Pharm Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Aju Pharm Co., Ltd., initiated 2025-12-17. It names 5 FDA 510(k) clearances: K233601, K230892, K222423 and 2 more. Product: Fixone Hybrid Anchor. Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage..
- Recalling firm
- Aju Pharm Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-17
- Firm location
- Seongnam, N/A, Korea (the Republic of)
510(k) clearances named in this recall
5 on FDA's record- K233601 — Fixone Meniscal Repair
- K230892 — Fixone Biocomposite Anchor
- K222423 — Fixone All Suture Anchor
- K203523 — Fixone hybrid knotless anchor
- K193497 — Fixone Biocomposite Interference Screw
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Fixone Hybrid Anchor
Reason for recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.