Medical device recalls Moderate risk

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Mitek Screw and Washer Depth Gauge, Product Code 219024

Recall date
August 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0208-2019
FDA classification
Class II
Brand / firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Sold / distributed
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,…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mitek Screw and Washer Depth Gauge, Product Code 219024

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