Z-0536-2013Class II

Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Name: Z-0536-2013 Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Creator: Ebi, Llc
Published: 2012-09-29
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2012-09-29 / Terminated / root cause: manufacturing process

FDA source

Ebi, Llc began a recall of Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 on 2012-09-29. FDA classified it as Class II and gives the reason as "Broken screw insertor hardness was measured and found to be below the acceptable limits". 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-0536-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-29
Posted: 2012-12-17
Terminated: 2015-12-07
Recalling firm: Ebi, LLC
Product: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Product code: HXX Screwdriver
Reason for recall: Broken screw insertor hardness was measured and found to be below the acceptable limits.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.
Quantity in commerce: 15 units
Distribution: Nationwide Distribution, including the states of MO, TX, and IN.
Product codes and lots: Lot Numbers 540199, 540199-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0536-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0536-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

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)