Reported May 20, 2015 · Terminated

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in…

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?

  • Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only
  • Product Usage UsageSurgical instruments used in preparation for dental implant placement
Lot codes and dates
  • Lot Number 1501968
Amount recalled
48 units

Where it was sold

Why it was recalled

BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

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 Aug 7, 2015 · Data as of Sep 19, 6:49 PM UTC

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