Zimmer Biomet, Inc. recalls 36MM COCR MODULAR HD -6MM

Recall date

September 15, 2017

Source

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

Recall number

Z-1008-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Outside USA

Why it was recalled

One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

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

What was recalled

36MM COCR MODULAR HD -6MM