Z-0359-2014 Class II Terminated
FDA device recall Z-0359-2014 was initiated by Ebi, Llc on August 22, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 31, 2016). Affected quantity: 7,092 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2013
- Initiation Date
- August 22, 2013
- Termination Date
- August 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,092 units
Product Description
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
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 Pattern
Nationwide distribution including Puerto Rico.
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.