Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smith & Nephew, Inc.
- Reason for Recall:
- Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Product Codes/Lot Numbers:
Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
Distribution:
Distributed in: AZ, ME, NY, OH, PA, TN, VT, PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1536-2018
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Smith & Nephew
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Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.