{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "114542", "product_res_number": "Z-0537-2013", "event_date_initiated": "2012-11-19", "event_date_posted": "2012-12-18", "recall_status": "Terminated", "event_date_terminated": "2014-04-17", "res_event_number": "63641", "product_code": "JDC", "k_numbers": [ "K973357" ], "product_description": "COONMAD/MORREY TOTAL ELBOW\r\nELBOW COMPONENT REPLACEMENT SET\r\nBUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW\r\nELBOW COMP REPLACEMENT-REG SET\r\nSTERILE PROD CLASS: 4100\r\nOPERATION:9000\r\nQTY/PKG:1\r\n\r\n\r\nProduct Usage:\r\nThe ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.", "code_info": "Catalog 32-8106-000-03; Lot 61644802", "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": "Roberto Munoz\n574-372-4807", "reason_for_recall": "Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .", "root_cause_description": "Process change control", "action": "Zimmer sent \"URGENT MEDICAL DEVICE RECALL\" letter dated November 19, 2012 to Distributors, Risk Managers/ Implanting Surgeons, and direct accounts. The notice describes the product, problem, risks and actions to be taken. Consignees were instructed to immediately locate, quarantine and return affected product with the completed Inventory Return Certification form to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 (US accounts) or Zimmer International Logistics GmbH, ATTN: Fao Tanja Herold (Recall Warsaw), Max-Immelmann-Allee 12 79427 Eschbach Germany for international accounts. If an implant is removed from customer inventory, they were directed to provide a copy of the Risk Manager letter upon retrieval of that implant(s) to ensure all facilities are aware of the removal. Surgeons are asked to consider risk information in the letter should a patient present with unexplained symtoms. Hospitals that received direct shipments from the Warsaw Distribution Center will be sent a copy of the Risk Manager letter directly. Questions and concerns along with information on any implanted product is to be addressed to CorporateQuality.PostMarket@zimmer.com using the provided spreadsheet or contact Zimmer at 1-800-447-5633.", "product_quantity": "23", "distribution_pattern": "Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.", "openfda": { "k_number": [ "K181307", "K980428", "K973357", "K033280", "K883665", "K861680", "K872084", "K955916", "K013042", "K901581", "K090473", "K040389", "K123862", "K153398", "K980502", "K181362", "K001989", "K000003", "K051975", "K992656", "K003253", "K150501", "K904021", "K053189", "K000683", "K060696", "K982398", "K042664", "K983036" ], "registration_number": [ "3011683674", "3033509898", "1721686", "2245304", "1526534", "3017397663", "9681465", "3010041511", "1424263", "1450662", "3026771806", "1828288", "1220477", "3014302784", "3035366890", "3009518015", "3003387384", "3013176080", "3004976965", "3009888740", "1061124", "3014315560", "3010178296", "3008021110", "1835251", "3000931034", "3036756245", "3015207155", "3002807295", "1825034", "3004371426", "9614841", "1834331", "1721676", "1822565", "3015859709", "2528981", "3011015572", "3002806603", "3013791180", "2249615", "1645151", "3015542154", "3002806470", "3011274144", "1221934", "1226544", "3010041993", "3003639920", "3004983210", "3009887475", "3010057495", "3011461101", "1828464", "2242737", "1649390", "3005061536", "3007993775", "3004153896", "1529009", "2249697", "1644408", "9680794", "3008395353", "3008337808", "1834379", "1423662", "3009888344", "1818910", "3025603301", "1526350", "3006017180", "3007740680" ], "fei_number": [ "3011683674", "1000512168", "3000205591", "3033509898", "1721686", "2245304", "1526534", "3017397663", "3010041511", "1450662", "3003015552", "1000306340", "1828288", "3026771806", "3002808402", "1220477", "3014302784", "3035366890", "1000149660", "3009518015", "3003387384", "1000118610", "3013176080", "3006017180", "3004976965", "3009888740", "3036756245", "3014315560", "3000215273", "3008021110", "3000931034", "3001049282", "3002807113", "3015207155", "3002807295", "1825034", "1000116912", "3003128516", "3003070421", "1721676", "3015859709", "2528981", "3011015572", "3002806603", "3013791180", "3015542154", "3000718467", "3002806470", "3011274144", "1221934", "3010041993", "3003639920", "3004983210", "3009887475", "1000220733", "3010057495", "3011461101", "1828464", "1000306303", "3005061536", "3003737899", "3007993775", "3004153896", "3008395353", "3003386935", "3008337808", "3009888344", "3001548076", "1818910", "3025603301", "1526350", "3003110073", "3007740680" ], "device_name": "Prosthesis, Elbow, Constrained, Cemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3150", "device_class": "2" } } ] }