Class II — Ebi, Llc
| Recalling firm | EBI, LLC - AHP EOS Buyer Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Increased risk of failure at the driver tip during screw insertion or removal. |
| 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. |
| Quantity | 59 units. |
| Distribution | Nationwide Distribution including the states of AL, IN, MO, NE TN and TX. |
| Initiated | 2013-02-07 |
| Classified | 2013-03-15 |
| Terminated | 2015-12-07 |
| Recall number | Z-0954-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ebi, Llc (Z-0954-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64452/
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