ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to te

FDA device recall Z-0296-2013 · posted 2012-11-15 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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 back form/acknowledgement certification to 1-888-429-7380 or email it to zimmer3611@stericycle.com. Questions should be directed to 1-8889435167 between 8 a.m. and 5 p.m. EDT. For questions regarding this recall call 574-372-4807.

Root cause

Counterfeit

Status

Terminated

Product code

KCY

Quantity affected

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.

Date initiated

2012-09-05

Date posted

2012-11-15

Date terminated

2014-04-17

Location

Warsaw, IN