FDA-Device2012-12-26Class II
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.
Biomet, Inc.
Hazard
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Sold states
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Affected count
49
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0527-2013Don't want to check this manually?
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