# FDA recall Z-0208-2019

> **DePuy Mitek, Inc., a Johnson & Johnson Co.** · Class II · device recall initiated 2018-08-30.

## 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

- **Recall number:** Z-0208-2019
- **Recalling firm:** DePuy Mitek, Inc., a Johnson & Johnson Co.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0208-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0208-2019. Source: US FDA. Licensed CC0.

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