FDAApril 16, 2015device

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

biohorizons implant systemsbiohorizonsbiohorizons implant

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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