Shortened Plug Driver — Class II medical device recall Z-0411-2014
Terminated recall by Ebi, Llc, reported 2013-12-04, distributed in CA. Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal
| Recall number | Z-0411-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2013-09-24 |
| Classified | 2013-11-27 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-05-15 |
| Distributed | CA |
| Quantity | 2 units |
| Lot numbers | 184090 |
| Model numbers | LV00407 |
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 discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Reason for recall
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
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-0411-2014. 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.