Biomet Spine Polaris 5 — Class II medical device recall Z-0954-2013
Terminated recall by Ebi, Llc, reported 2013-03-27, distributed nationwide. Increased risk of failure at the driver tip during screw insertion or removal.
| Recall number | Z-0954-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2013-02-07 |
| Classified | 2013-03-15 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2015-12-07 |
| Distributed | Nationwide (US) |
| Quantity | 59 units |
| Lot numbers | 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613, 546613-1 |
| Model numbers | 14-500178 |
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 for recall
Increased risk of failure at the driver tip during screw insertion or removal.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0954-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.