Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # PN625.
- 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:
- Integra LifeSciences Corp.
- Reason for Recall:
- The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Product Codes/Lot Numbers:
Lot # PN625.
Distribution:
Distributed in: US, FL, VA, OK, CO, DC, IN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2296-2016
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