Z-0411-2014Class II

Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ...

Name: Z-0411-2014 Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ...
Creator: Ebi, Llc
Published: 2013-09-24
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2013-09-24 / Terminated / root cause: manufacturing process

FDA source

Ebi, Llc began a recall of Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a... on 2013-09-24. FDA classified it as Class II and gives the reason as "Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-24
Posted: 2013-11-27
Terminated: 2015-05-15
Recalling firm: Ebi, LLC
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
Product code: HXX Screwdriver
Reason for recall: Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet sent an Urgent Medical Device Recall Letters/Fax Back Response Form dated September 24, 2013, via Fed Ex. The customer is asked to examine their inventory and return the recalled product following the attached instructions. The Fax Back Response Form should be completed and returned to 973-887-1347 prior to the return of the product. Any questions please call (973) 299-9300 x 2162.
Quantity in commerce: 2 units
Distribution: US Distribution to CA
Product codes and lots: Device listing # D090878 Catalog # LV00407 Lot #184090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)