Zimmer Biomet Reusable Surgical Cuffs are designed and manufactured to ensure superior convenience, comfort and safety in any tourniquet application. With the expanded line of Contour and Small Adult Cuffs, the clinician can feel secure that procedural demands will be met without sacrificing patient comfort and safety. The following medical tourniquet features can help you create “Your Circle of Confidence.” Contour and Small Adult Cuffs.
Engineered to fit virtually any size or shape of limb, providing the ultimate in patient comfort and clinician confidence. Protection Sleeves Designed to complement Zimmer Biomet tourniquet cuffs and protect the patient from soft tissue damage. 90-Degree Ports Help keep hoses clear of the surgical site. Reusable Slim design means easy cleaning for comfortable wearing, time and time again. Single/Dual Bladder Options Offers clinicians convenient choices for cuff style and sizing. Single bladder cuffs available in all sizes. Dual bladder cuffs available in selected sizes.
Zimmer - ATS 3000A calculated response for optimal pressure, The A.T.S. 3000 Automatic Tourniquet System is a dual-port, dual-cuff system with.
Positive Locking Connectors Helps prevent unintentional detachment from regulator hoses. High Quality Material Latex-free and durable, manufactured to withstand any procedural demand. Low-Profile Design Slim and lightweight for enhanced performance and patient comfort. Designed to provide less surgical obstruction. Single/Dual Port Options All cuff styles are available in both single and dual port configurations, allowing for use with any A.T.S. tourniquet regulator.
Single port cuffs for use with Zimmer single port Tourniquet Systems. Dual port cuffs for use with Zimmer dual port Tourniquet Systems. Zimmer Biomet offers the most comprehensive line of surgical tourniquet cuffs on the market: Contour Cuffs. – For use when standard A.T.S. Cylindrical Cuffs do not conform to actual limb shapes. Designed for superior fit and performance on contoured adult limbs. Unique design and adjustable fasteners allow a superior fit on a wide range of limb shapes and sizes.
Small Adult Cuffs. – For use when regular adult tourniquet cuffs are wider or longer than required for surgery. Unique P-shaped design minimizes tourniquet-related obstruction of the surgical site. Comes in Extra Small (3 in. 8cm wide) and Small (3.5 in. Manufactured by Delfi Medical Innovations, Inc. Reusable Cuffs.
Available in A.T.S. Cylindrical,Contour or Small Adult styles. Durable, high-quality material for longer wear. Single and dual-bladder options. Single and dual-port options Limb Protection Sleeves.
Specific designs for A.T.S. Cylindrical,Contour, and Small Adult Cuffs. Shown to be more effective than other forms of limb protection 1. Helps protect skin from wrinkling, pinching and shearing.
Helps prevent tourniquet contamination. Does not clog cuff closure material. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. This material is intended for health care professionals. Distribution to any other recipient is prohibited. For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website.
To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.
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. 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. 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.
Zimmer Ats 1500 Service Manual
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.
Zimmer Ats 1200 Service Manual
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.
Zimmer Ats 750 Service Manual
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. 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. This record will be updated as the status changes.