Reported Dec 16, 2015 · Terminated

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental…

BioHorizons Implant Systems Inc.

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: BioHorizons Implant Systems Inc · 2300 Riverchase Ctr · Hoover, AL · 35244-2808

Is this the product you have?

  • RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
Lot codes and dates
  • Lot 1404442
Amount recalled
32 units

Where it was sold

Why it was recalled

An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

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 Feb 4, 2016 · Data as of Sep 19, 5:20 PM UTC

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