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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 Recall
Biomet Polaris 5.5
see related information
Date Posted December 17, 2012
Recall Status1 Open
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/
Manufacturer
Ebi, Llc
100 Interpace Pkwy
Parsippany, New Jersey 07054-1149
For Additional Information Contact Mr. David M. Talish
973-299-9300
Manufacturer Reason
for Recall
Broken screw insertor hardness was measured and found to be below the acceptable limits.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
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