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 | Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. |
| Product | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as… |
| Quantity | 2 units |
| Distribution | US Distribution to CA |
| Initiated | 2013-09-24 |
| Classified | 2013-11-27 |
| Terminated | 2015-05-15 |
| Recall number | Z-0411-2014 |
| 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-0411-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66654/
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