IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 — recall Z-0774-2016
U.S. FDA — Device Enforcement · United States · 2016-01-06 · Class II
As described by U.S. FDA — Device Enforcement: IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Imm
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution. US Nationwide in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Pol
Reported risk: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
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