CLASS II Device recall · Reported 27 Mar 2013 · FDA Enforcement Report

Biomet Spine Polaris 5 Button Lock Screw Inserter recalled by Ebi

Ebi is recalling Biomet Spine Polaris 5 Button Lock Screw Inserter, distributed nationwide in the US. The recall was initiated on 7 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

Quantity recalled59 units.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0954-2013
FDA event ID: 64452
Recalling firm: Ebi, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2013
FDA classified: 15 Mar 2013
Reported: 27 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

7 Feb 2013	Recall initiated by company
15 Mar 2013	Classified by FDA	+36 days
27 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Increased risk of failure at the driver tip during screw insertion or removal.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

Nationwide Alabama Indiana Missouri Nebraska Tennessee Texas

Questions about this recall

Is Biomet Spine Polaris 5 Button Lock Screw Inserter recalled?

Yes. Ebi recalled Biomet Spine Polaris 5 Button Lock Screw Inserter on 7 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0954-2013.

Why was it recalled?

Increased risk of failure at the driver tip during screw insertion or removal.

Which lots are affected?

Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

Where was it sold?

Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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