FDA Device recall Z-0359-2014
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System by Ebi, citing 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 T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0359-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-22 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) u…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0359-2014%22
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