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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Riverpoint Medical, LLC: Iconix Knotless 1.4mm Anchors Recalled for Risk of Suture Damage and Breakage

Agency Publication Date: December 8, 2023
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Summary

Riverpoint Medical, LLC is recalling 999 units of Iconix Knotless 1.4mm Anchors with XBraid S (Blue/Black and Black/White models). These medical devices, used for attaching soft tissue to bone in joints like the shoulder and knee, can fail when used in hard bone conditions. Specifically, the tool used to insert the anchor can bend or move, which may damage or break the surgical suture during insertion. No specific injuries were reported in the announcement, but the defect can lead to surgical complications or failed repairs. Consumers and medical professionals should verify if they have the affected product codes and lot numbers.

Risk

If the inserter tool bends or moves during a procedure, it can damage the suture material. This damage can cause the suture to break during use, potentially leading to surgical delays or the failure of the tissue-to-bone fixation.

What You Should Do

  1. Identify if you have the affected products: Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) or Iconix Knotless 1.4mm Anchor with XBraid S (Black/White).
  2. Check your product packaging for Product Code 3911-7 14-520 with Lot Number 23080433 (UDI-DI 00840277402172).
  3. Check your product packaging for Product Code 3911-7 14-521 with Lot Number 23081617 (UDI-DI 00840277402189).
  4. Contact your healthcare provider or Riverpoint Medical, LLC at 1-800-445-2993 for further instructions regarding the use or return of these devices.
  5. If you are a medical provider, stop using the affected lots immediately and segregate them from your inventory.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black)
Model / REF:
3911-714-520
UDI-DI: 00840277402172
Lot Numbers:
23080433
Product: Iconix Knotless 1.4mm Anchor with XBraid S (Black/White)
Model / REF:
3911-714-521
UDI-DI: 00840277402189
Lot Numbers:
23081617

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93390
Status: Active
Manufacturer: Riverpoint Medical, LLC
Manufactured In: United States
Units Affected: 999 devices
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.