FDA-Device2014-12-03Class II
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Zimmer, Inc.
Hazard
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
Sold states
Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.
Affected count
1165 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0423-2015Don't want to check this manually?
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