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
This recall has been terminated (originally issued November 19, 2013).
- Company
- Ebi, Llc
- Recall Initiated
- August 22, 2013
- Posted
- November 19, 2013
- Terminated
- August 31, 2016
- Recall Number
- Z-0359-2014
- Quantity
- 7,092 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution including Puerto Rico.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.