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Biomet, Inc. recalls EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fix
Recalled December 26, 2012 · FDA recall Z-0527-2013 · Biomet
Hazard
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp. · FDA Class II
Units
49
Sold at
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Description
It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Product
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.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →