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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Mitek Screw and Washer Depth Gauge, Product Code 219024
Recalled October 31, 2018 · FDA recall Z-0208-2019 · DePuy Mitek, Inc., a Johnson & Johnson
Hazard
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole. · FDA Class II
Units
401
Sold at
US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.
Description
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
Product
Mitek Screw and Washer Depth Gauge, Product Code 219024
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →