Zimmer, Inc. recalls Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-…

Recall date

November 24, 2015

Source

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

Recall number

Z-0410-2016

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.

Why it was recalled

Complaints that the ratchet teeth of the tube are not latching onto the rod.

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

What was recalled

Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.