| Class 2 Device Recall ATS 3000 Automatic Tourniquet System | |
Date Initiated by Firm | September 05, 2012 |
Date Posted | November 15, 2012 |
Recall Status1 |
Terminated 3 on April 17, 2014 |
Recall Number | Z-0296-2013 |
Recall Event ID |
63458 |
Product Classification |
Tourniquet, pneumatic - Product Code KCY
|
Product | 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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | Jaime L. Weeks 574-372-4807 |
Manufacturer 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 |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|