{ "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": "156246", "product_res_number": "Z-0200-2018", "event_date_initiated": "2017-05-16", "event_date_created": "2017-12-06", "recall_status": "Terminated", "event_date_terminated": "2021-04-22", "res_event_number": "77479", "product_code": "HSN", "k_numbers": [ "K152217" ], "product_description": "Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., \n\n\nIntended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.", "code_info": "Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024", "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": "Possible inner labeling and packaged device not matching the outer label on the box.", "root_cause_description": "Under Investigation by firm", "action": "Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. 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