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Terminated

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .

FDA Recall Z-0612-2018 · Posted None

Recalling FirmZimmer Surgical Inc
Recall StatusTerminated
Product CodeKCY
Date Initiated2017-07-27
Date Terminated2019-08-01
Product Quantity8,231 devices total

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.

Firm Action

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE CORRECTIONS" letter dated 7/27/2017 to its customers via email or mail. The letter describes the product, problem and actions to be taken. Instructions for distributors include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, review the hospital list of customers that accompanied the notice and return contact information for any additional hospitals product was distributed to. Instructions for Risk Managers at hospitals include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, and complete and return the Attachment 1 form via email to [email protected] or [email protected] or fax to 866-338-2611. If after reviewing this notification you have further questions or concerns please call +1(330) 364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency.

Root Cause

Use error

Distribution Pattern

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..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc. · 2013-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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