Zimmer Biomet, Inc. recalls Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to faci…

Recall date

May 11, 2016

Source

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

Recall number

Z-1917-2016

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa,…

Why it was recalled

Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.

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 Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.