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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