Class 2 Device Recall A.T.S. 2200TS Tourniquet Systems Date Initiated by Firm July 27, 2017 Create Date February 14, 2018 Recall Status Open, Classified Recall Number Z-0613-2018 Recall Event ID Product Classification - Product Code Product A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc.

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2. Zimmer Ats 750 Service Manual

Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Code Information Lot No.

62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No.

62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No.

62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No.

62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No.

62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No.

62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No.

62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No.

62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No.

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62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No.

62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 62885586 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 62885587 (Serial Numbers: 06, 07, 08, 09, 10, 11, 12, 13, 14, 15); Lot No.

62895898 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 62905257 (Serial Numbers: 01); Lot No. 62904091 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

62904093 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 62879139 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 62905838 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 62895896 (Serial Numbers: 01, 02, 03, 04, 05); Lot No.

62904123 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 62932244 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 62935217 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 62937693 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 62945082 (Serial Numbers: 01, 02, 03, 04, 05); Lot No.

62945086 (Serial Numbers: 06, 07, 08); Lot No. 62932650 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2); Lot No. 62961804 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 62976480 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 62976481 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63026460 (Serial Numbers: 01, 02, 03, 04, 05); Lot No.

63007852 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Lot No. 63042181 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63042182 (Serial Numbers: 06, 07, 08, 09, 10); Lot No.

63007853 (Serial Numbers: 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30); Lot No. 63042179 (Serial Numbers: 01, 02, 03); Lot No. 63042184 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63037252 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63042180 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63042183 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63037254 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63092209 (Serial Numbers: 01, 02, 03); Lot No. 63092210 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63072301 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63103587 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15); Lot No. 63072324 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63103164 (Serial Numbers: 21, 22, 23); Lot No. 63072352 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63096468 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63109655 (Serial Numbers: 01, 02, 03); Lot No. 63103590 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15); Lot No. 63109651 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63116357 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63123305 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63138553 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63138631 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63171089 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63202480 (Serial Numbers: 01, 02, 03, 04, 05); Lot No.

63202478 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63234563 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63234565 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63212407 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63245752 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07); Lot No. 63253256 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63247425 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63526287 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63531691 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07); Lot No. 63526321 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63261584 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63264374 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63265280 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07); Lot No.

63257987 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63271202 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63258039 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63278388 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63278436 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63314121 (Serial Numbers: 01, 02, 03); Lot No. 63314118 (Serial Numbers: 01, 02, 03); Lot No. 63324625 (Serial Numbers: 01, 02, 03); Lot No. 63336959 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No.

63314042 (Serial Numbers: 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30); Lot No. 63341344 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63341346 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63314117 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63352349 (Serial Numbers: 01, 02, 03); Lot No.

63339440 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63343366 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22); Lot No. 63352347 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63339497 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63378855 (Serial Numbers: 01, 02, 03); Lot No.

63369605 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63403010 (Serial Numbers: 21, 22, 23); Lot No.

63403012 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08); Lot No. 63403026 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63403009 (Serial Numbers: 01, 02, 03); Lot No. 63403024 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63403025 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63403017 (Serial Numbers: 11, 12, 13, 14, 15); Lot No. 63394148 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63410582 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15); Lot No. 63422767 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63410583 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63410585 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63394176 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63430499 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63437710 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63436338 (Serial Numbers: 01, 02, 03, 04, 05); Lot No.

63445193 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63430540 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63445194 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63455066 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63474281 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63474283 (Serial Numbers: 21, 22, 23, 24, 25, 26); Lot No. 63474284 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08); Lot No.

63474287 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10); Lot No. 63474285 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15); Lot No. 63455098 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63474282 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

Zimmer Ats 4000 Service Manual

63484747 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63482404 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63482405 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63482408 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 10012, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63501470 (Serial Numbers: 21, 22, 23, 24, 25); Lot No. 63501471 (Serial Numbers: 21, 22, 23, 24, 25); Lot No. 63501459 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No.

63501486 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63501469 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18); Lot No. 63531693 (Serial Numbers: 01, 02, 03, 04, 05); Lot No. 63501509 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63501547 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20); Lot No. 63501493 (Serial Numbers: 01, 02, 03, 04, 05, 06, 07, 08) Recalling Firm/ Manufacturer Zimmer Surgical Inc 200 W Ohio Ave Dover OH For Additional Information Contact 330-343-8801 Manufacturer Reason for Recall Updated on-device label and 3 pages of an updated Operator/Service Manual.

Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment. FDA Determined Cause Use error Action The firm, Zimmer Biomet, sent an 'URGENT MEDICAL DEVICE CORRECTIONS' letter dated 7/27/2017 to its customers via email or mail. The letter describes the product, problem and actions to be taken. Instructions for distributors include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, review the hospital list of customers that accompanied the notice and return contact information for any additional hospitals product was distributed to. Instructions for Risk Managers at hospitals include ensure all affected personnel are aware of the recall, confirm receipt of new device label and updated Operator/Service Manual, place the label on the device in the location specified in the notice, replace the 3 pages of the Operator/Service Manual with the updated pages, and complete and return the Attachment 1 form via email to corporatequality.postmarket@zimmerbiomet.com or ZimmerBiomet8287@stericycle.com or fax to 866-338-2611. If after reviewing this notification you have further questions or concerns please call +1(330) 364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Quantity in Commerce 8,231 devices total Distribution Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand.

Total Product Life Cycle 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. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed.

Zimmer Ats 750 Service Manual

This record will be updated as the status changes.