FDA-Device2016-06-15Class II
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
Zimmer Biomet, Inc.
Hazard
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.
Sold states
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, Spain, Sweden, Switzerland, and United Arab Emirates.
Affected count
10,256
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1917-2016Don't want to check this manually?
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