# FDA recall Z-0613-2018

> **Zimmer Surgical Inc** · Class II · device recall initiated 2017-07-27.

## Product

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure.  Zimmer Surgical, Inc. Dover, OH 44622     Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

## Reason for recall

Updated on-device label and 3 pages of an updated Operator/Service Manual.  Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

## Distribution

Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..

## Key facts

- **Recall number:** Z-0613-2018
- **Recalling firm:** Zimmer Surgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-27
- **Report date:** 2018-02-21
- **Termination date:** 2019-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dover, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0613-2018

## Citation

> AI Analytics. FDA recall Z-0613-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0613-2018. Source: US FDA. Licensed CC0.

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