Tapered HD Upgrade Set recalled over sterility concerns

Recall date

April 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BioHorizons Implant Systems Inc recalls Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparatio…

Recall number

Z-1605-2015

FDA classification

Class II

Brand / firm

BioHorizons Implant Systems Inc

Sold / distributed

US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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