{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94423", "product_res_number": "Z-0573-2011", "event_date_initiated": "2010-09-10", "event_date_posted": "2010-12-09", "recall_status": "Terminated", "event_date_terminated": "2012-09-14", "res_event_number": "56731", "product_code": "KWT", "k_numbers": [ "K041549", "K050761", "K052906", "K060704" ], "product_description": "TRABECULAR METAL\" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00.\nThe intramedullary reamer is used to open the mid to distal humeral canal to accept the implant.", "code_info": "Catalog Number 00-4312-020-00.   All lot numbers.", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "574-372-4807", "reason_for_recall": "The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.", "root_cause_description": "Device Design", "action": "Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:\na. provide the Dear Surgeon (Urgent Device Correction) letter and revised\nsurgical technique directly to surgeons and risk managers at facilities using\nthe device or\nb. provide a list of facilities and surgeons using the TM Humeral and TM\nReverse shoulder systems to the Zimmer Recall Coordinator, and\nc. destroy previous versions of the surgical technique, and\nd. inform users of when the new surgical technique, instrument case, distal\nreamers, and distal pilots will be shipped to them based on communication\nfrom Zimmer, Inc.\nHandling of returned product:\nHCPs were notified to return all of the distal pilots in the scope back to\nZimmer which were to be be destroyed once the recall has been completed. They will\nalso be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the\nBigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by\nZimmer Sales Representatives.\nFor questions regarding this recall call (574) 371-8852.", "product_quantity": "13,093 total reamers in distribution.", "distribution_pattern": "Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.", "openfda": { "k_number": [ "K872454", "K873621", "K241817", "K962238", "K022377", "K210899", "K960424", "K032507", "K251686", "K940537", "K041549", "K014049", "K222482", "K982981", "K071147", "K915596", "K914000", "K042321", "K110706", "K143659", "K121543", "K223631", "K173812", "K241944", "K231657", "K182500", "K873104", "K802124", "K020045", "K831234", "K101263", "K895802", "K190595", "K922865", "K831233", "K181287", "K110791", "K002998", "K191698", "K161476", "K123814", "K022079", "K905786", "K790987", "K191811", "K962315", "K970567", "K984541", "K833409", "K010869", "K961571", "K931114", "K111746", "K162903", "K152825", "K050761", "K100858", "K023063", "K250713", "K914695", "K873620", "K962244", "K103404", "K991585", "K030710", "K192365", "K043505", "K140071", "K150730", "K991603", "K925613" ], "device_name": "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3650", "device_class": "2", "registration_number": [ "1020279", "3009116370", "8010916", "3004983210", "2029275", "3011189525", "1822565", "1828288", "3009973505", "3013055499", "1423662", "9613350", "3005144609", "3015916578", "1644408", "3010314800", "3009417901", "3009971621", "3000931034", "3015542154", "1828464", "3010375065", "3010178296", "3010386387", "1825034", "2133928", "3009882462", "3010065126", "1835572", "8043792", "3010383847", "3009475821", "3007923096", "3000264985", "3014315560", "3010287737", "3017397663", "3011274144", "1836116", "3007993775", "1827096", "3009153862", "3009888740", "3008337808", "3020745236", "3007051929", "3014680795", "9681465", "3008388276", "1645151", "3011061242", "3013086329", "3006563559", "3012523063", "1649518", "3014128390", "3008868758", "1219655", "1833986", "3008102042", "3004748528", "3014302784", "1220477", "3005061536", "3008534770", "3009871135", "1000517406", "1450662", "3010370880", "3008812560", "3012725451", "3004513872", "3009887475", "1422572", "1835831", "3010009693", "3026771806", "3006128100", "9617840", "1038671", "3009546990", "3002808022", "3011015572", "1526534", "1226544", "1221934", "3008021110", "3016438694", "3004976965", "3012319330", "2183946", "1834331", "1835444", "3004641308", "3011683674", "9616944", "3012544635", "3020967480", "3008395353", "3006801265", "1057425", "3002806470", "1721676", "1424263", "3004371426", "1834379", "3009732568", "3013194153", "3027484613", "9616671", "3002807295", "1649390", "3033509898", "3005180920", "3012552981", "1818910", "3005913274", "1529009", "3007539489", "2249615", "3010057495", "3015399803", "3006356043", "1526350", "1000200989", "3008658204", "9611390", "3006001176", "3010039400", "3004153896", "3007740680", "3011500362", "3008110533", "3036756245", "3007441485", "3005751028", "2244478", "3025603301", "3010047402", "3010173425", "3013176080", "3035366890", "3006984710", "3002806603", "3003898228", "3009973844", "2030624", "3006017180", "2528981", "3015207155", "3015516266", "3006085220", "3011943495", "3013791180", "3009532798" ], "fei_number": [ "1020279", "3003128516", "1000116116", "3009116370", "1000118610", "3005233524", "3004983210", "3011189525", "3000717902", "3001452082", "1828288", "3009973505", "1000221916", "3013055499", "3005144609", "3015916578", "3010314800", "3009417901", "3009971621", "3000931034", "3015542154", "1828464", "3010375065", "3010386387", "1000220336", "1825034", "3009882462", "3010065126", "3002854251", "3000206435", "1000149660", "3010383847", "3009475821", "3007923096", "3002807036", "3000264985", "3014315560", "3010287737", "3017397663", "1000306340", "3011274144", "3007993775", "1827096", "3009153862", "3009888740", "3003569173", "3008337808", "3001236277", "3020745236", "3003110073", "1000220733", "3007051929", "3014680795", "1000306431", "1000136269", "3008388276", "3011061242", "3013086329", "3006563559", "3012523063", "3014128390", "3008868758", "1219655", "3004748528", "1000306303", "3014302784", "1220477", "3005061536", "3008534770", "3009871135", "1000517406", "1450662", "3010370880", "3008812560", "3012725451", "3003414678", "3004513872", "3009887475", "3001049282", "3010009693", "3026771806", "3006128100", "1038671", "3009546990", "3002808022", "3011015572", "3002808269", "1000116912", "1526534", "3003714383", "3002806773", "1221934", "3008021110", "3016438694", "3004976965", "3012319330", "3004641308", "3001814066", "3011683674", "3003386935", "3012544635", "3020967480", "3002687954", "3008395353", "3006801265", "3002806470", "1721676", "3000215273", "3009732568", "3013194153", "3027484613", "3002807295", "3033509898", "3005180920", "3012552981", "1818910", "3005913274", "3007539489", "1000139987", "3010057495", "3015399803", "3006356043", "1526350", "3002924544", "1000200989", "3000718467", "3008658204", "3006001176", "3010039400", "3004153896", "3007740680", "3011500362", "3008110533", "3036756245", "3007441485", "3005751028", "3003015552", "3025603301", "3010047402", "3002807113", "3013176080", "3035366890", "3006984710", "3002806603", "3003898228", "3009973844", "3006017180", "2528981", "3015207155", "3015516266", "3006085220", "3011943495", "3000717687", "3013791180", "3009532798" ] } } ] }