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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet The Polaris Spinal System; Shortened Plug Driver

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  Class 2 Device Recall Biomet The Polaris Spinal System; Shortened Plug Driver see related information
Date Initiated by Firm September 24, 2013
Date Posted November 27, 2013
Recall Status1 Terminated 3 on May 15, 2015
Recall Number Z-0411-2014
Recall Event ID 66654
Product Classification Screwdriver - Product Code HXX
Product Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054

The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Code Information Device listing # D090878 Catalog # LV00407 Lot #184090
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact Mr. Stephen Morey
303-501-8568
Manufacturer Reason
for Recall		 Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Biomet sent an Urgent Medical Device Recall Letters/Fax Back Response Form dated September 24, 2013, via Fed Ex. The customer is asked to examine their inventory and return the recalled product following the attached instructions. The Fax Back Response Form should be completed and returned to 973-887-1347 prior to the return of the product. Any questions please call (973) 299-9300 x 2162.
Quantity in Commerce 2 units
Distribution US Distribution to CA
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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