Reported Mar 27, 2013 · Terminated

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

Ebi, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ebi, Llc · 100 Interpace Pkwy · Parsippany, NJ · 07054-1149

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog Number 14-500178
  • Lot numbers
    • 543619
    • 543853
    • 543853-1
    • 543853-2
    • 544233
    • 544234-1
    • 546613 and 546613-1
Amount recalled
59 units.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 7, 2015 · Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.