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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Biomet Rail System		see related information
Date Posted December 17, 2012
Recall Number Z-0527-2013
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.
Code Information Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
Action On 11/9/2012 an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to all consignees (distributors and Doctor notices) informing them of the issue and providing recommended actions. Customer contact number (574) 372-1570 Monday through Friday from 8 am to 5 pm.
Quantity in Commerce 49
Distribution Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
 
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