Arthrex, Inc. recalls BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies…

Recall date

April 22, 2016

Source

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

Recall number

Z-1963-2016

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.

Why it was recalled

Potential for polystyrene particulate presence.

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

What was recalled

BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.