Exactech, Inc. recalls Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Recall date

July 11, 2017

Source

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

Recall number

Z-0603-2018

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.

Why it was recalled

Vix Bit may fracture during use.

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

What was recalled

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool