Iconix Knotless 1 — Class II medical device recall Z-0518-2024
Ongoing recall by Riverpoint Medical, LLC, reported 2023-12-20, distributed nationwide. Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of
| Recall number | Z-0518-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Riverpoint Medical, LLC, Portland, OR, United States |
| Recall initiated | 2023-10-25 |
| Classified | 2023-12-08 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 999 devices |
| UPC / GTIN / UDI-DI | 00840277402172, 00840277402189 |
| Lot numbers | 23080433, 23081617 |
| Model numbers | 3911-714-520, 3911-714-521 |
Product
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
Reason for recall
Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.
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-0518-2024. 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.