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Terminated

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.

FDA Recall Z-0296-2013 · Posted 2012-11-15

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeKCY
Date Initiated2012-09-05
Date Terminated2014-04-17
Product Quantity204

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

Firm 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 back form/acknowledgement certification to 1-888-429-7380 or email it to [email protected]. 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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE.

Official Source

View FDA Recall →

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

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