{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 221 } }, "results": [ { "cfres_id": "167190", "product_res_number": "Z-0012-2019", "event_date_initiated": "2018-08-21", "event_date_created": "2018-10-03", "recall_status": "Open, Classified", "res_event_number": "80996", "product_code": "KWT", "k_numbers": [ "K063569" ], "product_description": "Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00\n\nProduct Usage:\nShoulder surgery", "code_info": "Serial Numbers: 5214432, 5214445", "firm_fei_number": "1038671", "recalling_firm": "Exactech, Inc.", "address_1": "2320 NW 66th Ct", "city": "Gainesville", "state": "FL", "postal_code": "32653-1630", "additional_info_contact": "352-377-1140", "reason_for_recall": "The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.", "root_cause_description": "Under Investigation by firm", "action": "The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions:\n\" Immediately cease distribution or use of this product.\n\" Extend the information to their accounts that may have this product in their possession.\n\" Identify and quarantine any of the subject devices in their inventory\n\" Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.", "product_quantity": "2 units", "distribution_pattern": "In the countries of Australia and France", "openfda": { "k_number": [ "K022079", "K802124", "K231657", "K991603", "K984541", "K182500", "K043505", "K223631", "K961571", "K110706", "K110791", "K050761", "K250713", "K103404", "K140071", "K991585", "K181287", "K940537", "K002998", "K982981", "K905786", "K191811", "K121543", "K895802", "K970567", "K010869", "K931114", "K162903", "K152825", "K042321", "K873621", "K111746", "K161476", "K831234", "K914695", "K922865", "K041549", "K914000", "K191698", "K873104", "K150730", "K101263", "K790987", "K915596", 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"3009532798", "3003414678", "3010370880", "3013194153", "3002806603", "3012319330", "3010287737", "3002807036", "3002807113", "3014128390", "3008812560", "1526350", "3009546990", "3009971621", "3009871135", "3015916578", "3009888740", "3011943495", "3025603301", "3011189525", "3011274144", "3036756245", "1000200989", "3027484613", "3003386935", "3007923096", "1828288", "3000717902", "1000116912", "1000136269", "1818910", "3013086329", "3035366890", "3006563559", "3006128100", "3000206435", "3003110073" ], "device_name": "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3650", "device_class": "2" } } ] }