Recall Z-0296-2013 ยท KCY Tourniquet, Pneumatic
Zimmer, Inc.
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
| Date | Nov 15, 2012 (initiated Sep 5, 2012) |
| Status | Terminated |
| Reason | Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the |
| Root cause | Counterfeit |
| Action | Zimmer sent an Urgent Device Removal Notice letter dated September 5, 2012, to all affected customers. Zimmer Distributors and Sales Leadership were notified via E-mail of the pending recallthe product under recall beginnig September 11, 2012. The notification listed the reason for the recall, risks involved, and requested return of the unit for repair To: Zimmer Surgical, Attn: QAlRA Dept. - Recall, 200 West Ohio Avenue, Dover, Ohio 44622 USA The notice asked to ensure all users be made aware of the recall, remove the affected ATS 3000 tourniquest sytem for repair and return the fax bac |
| Quantity | 204 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.