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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 BIOSURE HA Screws Recalled for Labeling Error

Agency Publication Date: December 18, 2025
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Summary

Smith & Nephew, Inc. is recalling 168 units of BIOSURE HA Screws (6MM x 20 MM), which are threaded metallic fasteners used in bone fixation surgeries. The recall was initiated because of a labeling error on specific batches of the product. Affected units include model numbers 72201768 and 72204389 with batch numbers 51315219 and 51306803.

Risk

A labeling error on a surgical screw can lead to a surgeon selecting or using the incorrect device during a procedure. This could result in surgical delays or medical complications if the screw used does not match the specifications required for the patient's specific surgery.

What You Should Do

  1. This recall affects Smith & Nephew BIOSURE HA Screws (6MM x 20 MM), which are threaded metallic bone fixation fasteners.
  2. Identify affected products by checking for model numbers 72201768 or 72204389 and batch numbers 51315219 or 51306803 on the device packaging.
  3. Stop using the recalled device immediately. Surgical facilities and healthcare providers should quarantine any remaining stock of the affected lots.
  4. Contact Smith & Nephew or your medical device distributor to arrange for the return, replacement, or correction of the affected screws.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

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: BIOSURE HA SCREW, 6MM x 20 MM
Model / REF:
72201768
72204389
Lot Numbers:
51315219
51306803
UDI:
03596010611642
00885554036572

Threaded metallic bone fixation fastener.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98051
Status: Active
Manufacturer: Smith & Nephew, Inc.
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 168 units (US 83; OUS 85)
Distributed To: Alabama, California, Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, North Carolina, Nebraska, New York, Oklahoma, Tennessee, Texas, Utah

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.