Recall Z-0613-2018— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2017-07-27, terminated 2019-08-01. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-27
- Terminated
- 2019-08-01
- Firm location
- Dover, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.