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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 Initiated by Firm September 29, 2012
Date Posted December 17, 2012
Recall Status1 Terminated 3 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/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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