FDA Device recall Z-0954-2013
Biomet Spine Polaris 5.5 Button Lock Screw Inserter
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of Biomet Spine Polaris 5.5 Button Lock Screw Inserter by Ebi, citing increased risk of failure at the driver tip during screw insertion or removal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0954-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-07 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | US |
Product
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Reason
Increased risk of failure at the driver tip during screw insertion or removal.
Identifiers
| code_info | Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1. |
|---|
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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FDA Device · Class II · 2015-01-14 · Ebi
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2013%22
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