Riverpoint Medical recalls Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black/Black/White) due to risk of suture breaks from insertion failures in hard bone conditions. Affected units may cause damage to the suture construct during surgery.
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.
Riverpoint Medical is recalling Iconix Knotless 1.4mm Anchors with XBraid S for use in foot, ankle, knee, hip, hand, wrist, elbow, and shoulder surgeries. The anchors can fail in hard bone conditions, potentially damaging the suture construct and causing breaks during use.
Using a 1.4mm drill in hard bone conditions creates high insertion forces that can cause the inserter to bend. This bending may move the anchor off the drill hole, damaging the suture construct and leading to breaks during use.
Surgical professionals using the Iconix Knotless anchors for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow, or shoulder. Those with the specific product codes 3911-714-520 or 3911-714-521 are most at risk.
Check for the product codes 3911-714-520 (Blue/Black) or 3911-714-521 (Black/White) on the packaging. The anchors are intended for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder.
Identify if your anchor has product code 3911-714-520 (Blue/Black) or 3911-714-521 (Black/White) on the packaging.
Using a 1.4mm drill in hard bone conditions can cause the anchor to bend, move off the drill hole, and damage the suture construct, potentially leading to breaks during use.
Check for product codes 3911-714-520 (Blue/Black) or 3911-714-521 (Black/White) on the packaging.
The recall does not specify a stop-use action; the hazard requires caution in hard bone conditions, so users should check product codes and follow the manufacturer's guidance.
We’ve drafted a message you can send Riverpoint Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0518-2024 — Riverpoint Medical Riverpoint Medical Hello, I own a Riverpoint Medical that is covered by recall Z-0518-2024 from Riverpoint Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
