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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

Product Description 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.
Recall Number Z-0296-2013
Classification Class II
Code Info Catalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA
Product Distributed Qty 204
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 control board.

Event Detail

Event Id 63458
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.