Z-0954-2013Class II

Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a...

Name: Z-0954-2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a...
Creator: Ebi, Llc
Published: 2013-02-07
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2013-02-07 / Terminated / root cause: manufacturing process

FDA source

Ebi, Llc began a recall of 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 on 2013-02-07. FDA classified it as Class II and gives the reason as "Increased risk of failure at the driver tip during screw insertion or removal". 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-0954-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Posted: 2013-03-15
Terminated: 2015-12-07
Recalling firm: Ebi, LLC
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.
Product code: HXX Screwdriver
Reason for recall: Increased risk of failure at the driver tip during screw insertion or removal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.
Quantity in commerce: 59 units.
Distribution: Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Product codes and lots: Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0954-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0954-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

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)