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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 Polaris 5.5		see related information
Date Posted December 17, 2012
Recall Number Z-0536-2013
Product Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Code Information Lot Numbers 540199, 540199-1
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany, New Jersey 07054-1149
For Additional Information Contact Mr. David M. Talish
973-299-9300
Reason for
Recall		 Broken screw insertor hardness was measured and found to be below the acceptable limits.
Action Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
Quantity in Commerce 15 units
Distribution Nationwide Distribution, including the states of MO, TX, and IN.
 
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