Exactech, Inc. recalls Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

Recall date

August 21, 2018

Source

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

Recall number

Z-0012-2019

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

In the countries of Australia and France

Why it was recalled

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

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

What was recalled

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery