{ "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": 10 } }, "results": [ { "cfres_id": "84111", "product_res_number": "Z-0535-2010", "event_date_initiated": "2009-07-27", "event_date_posted": "2009-12-15", "recall_status": "Terminated", "event_date_terminated": "2010-03-15", "res_event_number": "52837", "product_code": "LRK", "k_numbers": [ "K981677" ], "product_description": "Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.\n\nDistributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. \n\nThe Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.", "code_info": "Lot # 62450300", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "904-296-9600", "reason_for_recall": "Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa.", "root_cause_description": "Labeling mix-ups", "action": "Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist.\n1. Fill-in the \"quantity on-hand \"column on the checklist.\n2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE\nField Action Contact Person for help to arrange for returns and replacements or credit.\n3. Fax your Checklist to Medtronic ENT at the number provided.\n4. Return products clearly marked.", "product_quantity": "7", "distribution_pattern": "9 consignees in the continental United States.", "openfda": { "k_number": [ "K122475", "K060388", "K170578", "K162192", "K093407", "K922984", "K232025", "K121344", "K250482", "K103076", "K093340", "K073004", "K181396", "K081965", "K964516", "K090503", "K251628", "K250028", "K991209", "K082849", "K191618", "K163580", "K252374", "K971794", "K882303", "K113022", "K181107", "K153200", "K955336", "K973884", "K222872", "K974531", "K962516", "K222127", "K895189", "K173064", "K062333", "K203606", "K231663", "K033822", "K182202", "K103004", "K250353", "K950763", "K121340", "K012142", "K160531", "K210203", "K061688", "K121285", "K993381", "K111110", "K250122", "K980952", "K183270", "K133390", "K090436", "K193239", "K140429", "K171576", "K210636", "K231138", "K200657", "K113126", "K926382", "K140435", "K153291", "K171316", "K060122", "K210910", "K062951", "K210694", "K221889", "K152292", "K261366", "K963063", 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