Exactech, Inc. recalls Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Recall date

November 7, 2016

Source

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

Recall number

Z-1030-2017

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

Why it was recalled

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

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

What was recalled

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.