FDA Devices Moderate Class II Terminated

Mitek Screw and Washer Depth Gauge, Product Code 219024

Reported: October 31, 2018 Initiated: August 30, 2018 #Z-0208-2019

Product 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.

Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Units Affected: 401
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.
Location: Raynham, MA

What product was recalled? ▼

Mitek Screw and Washer Depth Gauge, Product Code 219024. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 401.

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0208-2019.