Fixone Hybrid Anchor — Class II medical device recall Z-1166-2026
Ongoing recall by Aju Pharm Co., Ltd., reported 2026-02-04, distributed nationwide. Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and se
| Recall number | Z-1166-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aju Pharm Co., Ltd., Seongnam, N/A, Korea (the Republic of) |
| Recall initiated | 2025-12-17 |
| Classified | 2026-01-26 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 233 units |
| Reason classes | device malfunction |
| Model numbers | KAPN-47501NC, KAPN-55001C, KAPN-55001NA, KAPN-55001NC |
Product
Fixone Hybrid Anchor
Reason for recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1166-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.