EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
- 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:
- Biomet, Inc.
- Reason for Recall:
- It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Product Codes/Lot Numbers:
Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Distribution:
Distributed in: TX, TN, PA, CA, NY, FL, MI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0527-2013
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