Zimmer Biomet, Inc. recalls M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

Recall date

February 11, 2016

Source

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

Recall number

Z-1046-2016

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.

Why it was recalled

Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.

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

What was recalled

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093