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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

Smith & Nephew, Inc. Endoscopy Division: Sterility of device is compromised due to breach in sterile barrier

Agency Publication Date: July 14, 2014
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Affected Products

Product: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue

Lot Numbers: 50476555, 50481446

Lot Numbers:
Numbers
Product: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue

Lot Numbers: 50477397, 50481448

Lot Numbers:
Numbers
Product: SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899

Lot Numbers:
Numbers
Product: SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue

Lot Numbers: 50478983, 50478986, 50478989, 50482871, 50484944, 50485587, 50485589

Lot Numbers:
Numbers
Product: SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue

Lot Numbers: 50478984,50485736, 50485737, 50485738, 50487831, 50491901, 50493684

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68565
Status: Resolved
Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Manufactured In: United States
Units Affected: 5 products (259 units; 136 units; 907 units; 1086 untis; 763 units)

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.

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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 · 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.