FDAFDA · Food and drugs·Recall number Z-0527-2013
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.
Published December 26, 2012 · Recall initiated: November 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
- Lot
- Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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