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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

Smith & Nephew BIORAPTOR Suture Anchors Recalled for Packaging Defect

Agency Publication Date: November 29, 2024
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Summary

Smith & Nephew Inc. has recalled approximately 2,156 BIORAPTOR Suture Anchors, which are specialized medical devices used to attach tendons or ligaments to bone during surgery. The recall was issued because the packaging design was unable to maintain the device's geometry, leading to a breach in the sterile barrier. These anchors were distributed to hospitals and surgical centers nationwide and internationally.

Risk

A breach in the sterile packaging can allow bacteria and other contaminants to reach the medical device. Using a non-sterile anchor during surgery significantly increases the risk of post-operative infections and other serious medical complications for the patient.

What You Should Do

  1. This recall involves BIORAPTOR Suture Anchors, which are non-bioabsorbable bone anchors used for tendon and ligament repairs.
  2. Identify affected products by checking for part numbers 72201541, 72201542, 72203280, or 72203281 and Batch Numbers 2146369, 2151242, 2151690, 2154691, 2153489, or 2151692.
  3. Stop using the recalled devices immediately and remove them from surgical inventory.
  4. Contact Smith & Nephew Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BIORAPTOR Suture Anchors (Tendon/ligament, non-bioabsorbable bone anchor)
Model / REF:
72201541
72201542
72203280
72203281
Lot Numbers:
2146369
2151242
2151690
2154691
2153489
2151692
UDI:
03596010595072
03596010595089
03596010656452
03596010656469

Sterile barrier breach due to inadequate packaging design.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95654
Status: Active
Manufacturer: Smith & Nephew Inc.
Sold By: Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 2,156 units
Distributed To: Alaska, Alabama, Illinois, Indiana, Kentucky, Maryland, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, Texas

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.