Zimmer Biomet, Inc. recalls DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

Recall date

June 12, 2017

Source

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

Recall number

Z-0516-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland

Why it was recalled

A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture

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

What was recalled

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE