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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Spine Polaris 5.5 Button Lock Screw Inserter.

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  Class 2 Device Recall Biomet Spine Polaris 5.5 Button Lock Screw Inserter. see related information
Date Initiated by Firm February 07, 2013
Date Posted March 15, 2013
Recall Status1 Terminated 3 on December 07, 2015
Recall Number Z-0954-2013
Recall Event ID 64452
Product Classification Screwdriver - Product Code HXX
Product Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Code Information Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact Mr. David M. Talish
973-299-9300 Ext. 2322
Manufacturer Reason
for Recall		 Increased risk of failure at the driver tip during screw insertion or removal.
FDA Determined
Cause 2		 Process control
Action Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.
Quantity in Commerce 59 units.
Distribution Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
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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