Recall Z-0612-2018 ยท KCY Tourniquet, Pneumatic
Zimmer Surgical Inc
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. .
| Date | Jul 27, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| 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 inform |
| Quantity | 8,231 devices total |
| 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123553 | ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM Zimmer, Inc., Aug 9, 2013 |