FDA-Device2018-10-31Class II
Mitek Screw and Washer Depth Gauge, Product Code 219024
DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
Sold states
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.
Affected count
401
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
Mitek Screw and Washer Depth Gauge, Product Code 219024
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2019Don't want to check this manually?
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