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U.S. Department of Health and Human Services

Class 2 Device Recall ARRAY and POLARIS Spinal System

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  Class 2 Device Recall ARRAY and POLARIS Spinal System see related information
Date Initiated by Firm September 16, 2010
Date Posted October 22, 2010
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-0131-2011
Recall Event ID 56791
510(K)Number K062685  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product ARRAY and POLARIS Spinal System Medium Cross Connector
Non Sterile
Biomet Spine, Parsippany, NJ. 07054
Code Information Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact Michael Romaniw
973-299-9300 Ext. 2512
Manufacturer Reason
for Recall		 One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.
FDA Determined
Cause 2		 Other
Action Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken. Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form. Customers and distributors can contact Biomet at 1-800-526-2579.
Quantity in Commerce 82 units
Distribution Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = EBI, L.P.
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