FDA recall Z-0208-2019

DePuy Mitek, Inc., a Johnson & Johnson Co. · Class II · device

Product

Mitek Screw and Washer Depth Gauge, Product Code 219024

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-08-30
Report date
2018-10-31
Termination date
2020-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0208-2019