FDA Device recall Z-0411-2014
Shortened Plug Driver
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Shortened Plug Driver by Ebi, citing biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0411-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-24 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | CA |
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
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Identifiers
| code_info | Device listing # D090878 Catalog # LV00407 Lot #184090 |
|---|
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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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0411-2014%22
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