# FDA recall Z-0518-2024

> **Riverpoint Medical, LLC** · Class II · device recall initiated 2023-10-25.

## 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.

## Distribution

U.S. Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-0518-2024
- **Recalling firm:** Riverpoint Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-25
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portland, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0518-2024

## Citation

> AI Analytics. FDA recall Z-0518-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0518-2024. Source: US FDA. Licensed CC0.

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