Exactech, Inc. recalls Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

Recall date

February 13, 2015

Source

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

Recall number

Z-1459-2015

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.

Why it was recalled

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

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 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.