GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch No. 12GT20775
- 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:
- The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Product Codes/Lot Numbers:
Batch No. 12GT20775
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0448-2014
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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.