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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Polaris 5.5

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 Class 2 Device Recall Biomet Polaris 5.5 see related information
Date Posted December 17, 2012
Recall Status1 Terminated on December 07, 2015
Recall Number Z-0536-2013
Recall Event ID 63653
Product Classification Screwdriver - Product Code HXX
Product Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Code Information Lot Numbers 540199, 540199-1
Recalling Firm/
Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
973-299-9300 Ext. 3904
For Additional Information Contact Mr. David M. Talish
Manufacturer Reason
for Recall
Broken screw insertor hardness was measured and found to be below the acceptable limits.
FDA Determined
Cause 2
Process control
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.