Iconix recallZ-0518-2024 · Riverpoint Medical, LLC · initiated Oct 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Riverpoint Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
On 10/25/2023, the firm emailed its customer an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing them that the Iconix Knotless Anchor 's Instruction for Use is insufficient to prevent/avoid inserter buckling and insertion failure. The customers were instructed to do the following: - Immediately examine your inventory. If you have the part numbers listed above, notify end user with additional instructions for use. Users may continue to use field inventory once the acknowledgement letter has been completed. - Complete and return the response form as soon as possible to [email protected]. Mark the return shipments with RGA#2081- PDX. - Provide field correction information to any customers to whom you may have distributed or forwarded affected products. You may include a copy of the recall notice with your customer notification. - A copy of the notification letter and of IFU may be posted on or near the affected products, so users are aware of the additional instructions.
Recall details
- Recall number
- Z-0518-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 25, 2023
- Posted by the FDA
- Dec 8, 2023
- Recalling firm
- Riverpoint Medical, LLC
- Quantity
- 999 devices
- Product code
- MBI
- FDA submissions
- K231278
- Distribution
- U.S. Nationwide distribution in the state of CA.
Product description
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.
Code information (models, lots, serial numbers)
Product Code: 3911-7 14-520 UDI-DI Code: 00840277402172 Lot Number: 23080433 Product Code: 3911-7 14-521 UDI-DI Code: 00840277402189 Lot Number: 23081617
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Iconix 3911-714-520Riverpoint Medical, LLC · Fastener, Fixation, Nondegradable, Soft Tissue1 recall11 reports
- Iconix 3911-714-521Riverpoint Medical, LLC · Fastener, Fixation, Nondegradable, Soft Tissue1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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