{ "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": "216007", "product_res_number": "Z-0537-2026", "event_date_initiated": "2025-09-05", "event_date_posted": "2025-11-17", "recall_status": "Open, Classified", "res_event_number": "97588", "product_code": "PHX", "k_numbers": [ "K042021" ], "product_description": "Brand Name: Equinoxe Ergo\nProduct Name: Ergo Augments Pilot Tip Converter\nModel/Catalog Number: 301-11-11\nSoftware Version: N/A\nProduct Description: Pilot Tip Converter Piece\nComponent: Not a component", "code_info": "Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001", "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": "Darin Johnson\n+1-352-377-1140", "reason_for_recall": "Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.", "root_cause_description": "Release of Material/Component prior to receiving test results", "action": "On 09/05/2025, the firm emailed an \"URGENT MEDICAL DEVICE RECALL NOTICE\" to customers informing that, during routine inventory review, it was discovered that the a number of parts/products, which were pending design verification testing were incorrectly placed in active internal inventory rather than designated quarantine locations. Several part/products were distributed to customers.\n\nCustomers are instructed to:\n\"Carefully review this notification to ensure that they fully understand the issue and all actions required.\n\"Immediately identify, quarantine, and return any of the subject devices in their inventory and/or customer s inventory.\n\"Stop and cease use of any affected devices.\n\"Notify all their accounts that may have received these products and extend this recall notice, including the Description of Issue and Potential Clinical Impact, to them.\n\"Complete and Return the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com.\n\nFor questions or assistance - contact Recall Support Team at recalls@exac.com", "product_quantity": "1", "distribution_pattern": "U.S.: SC\n\nO.U.S.: N/A", "openfda": { "k_number": [ "K150488", "K252141", "K071948", "K191960", "K243643", "K062116", "K200368", "K173411", "K150568", "K181826", "K231911", "K260556", "K162325", "K082702", "K193099", 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