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U.S. Department of Health and Human Services

Class 2 Device Recall Polaris Translation Screw System

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  Class 2 Device Recall Polaris Translation Screw System see related information
Date Initiated by Firm August 22, 2013
Date Posted November 19, 2013
Recall Status1 Terminated 3 on August 31, 2016
Recall Number Z-0359-2014
Recall Event ID 66300
510(K)Number K123549  
Product Classification Screw, fixation, bone - Product Code HWC
Product BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile.

Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Code Information Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the  SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact
800-526-2579
Manufacturer Reason
for Recall		 Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
FDA Determined
Cause 2		 Device Design
Action Urgent Product Information notices dated 8/22/2013 were mailed via FedEx to distributors on 8/23/2013. Follow-up emails with a copy of the UPI notice were sent to distributors on 8/23/2013. The UPI notice informed the customers of the issue with the product and how to identify the affected product. Customers were advised that the Polaris Translation Screw System and the SpF Implantable Spine Fusion Stimulator not be used in conjunction with any implants containing cobalt chrome. Firm contacts were provided in case customers had any questions. EBI, LLC had a conference call with their domestic distributors on 8/23/2013 informing them they are required to notify their customers.
Quantity in Commerce 7,092 units
Distribution Nationwide distribution including Puerto Rico.
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 = HWC and Original Applicant = BIOMET SPINE (AKA EBI, LLC)
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