{ "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": "210611", "product_res_number": "Z-0500-2025", "event_date_initiated": "2024-09-30", "event_date_posted": "2024-11-21", "recall_status": "Open, Classified", "res_event_number": "95567", "product_code": "HSB", "k_numbers": [ "K232267" ], "product_description": "Precice Max REF:\nPM10.0-80B265\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm\n\t\nPM10.0-80B280\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm\n\t\t\nPM10.0-80B305\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm\n\t\nPM10.0-80B335\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm\n\t\nPM10.0-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm\n\t\nPM10.0-80TJ265\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 265mm\n\t\nPM10.0-80TJ280\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 280mm\n\t\nPM10.0-80TJ305\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 305mm\n\nPM11.5-80B265\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm\n\t\nPM11.5-80B280\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm\n\t\nPM11.5-80B305\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm\n\t\nPM11.5-80B335\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm\n\t\nPM11.5-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm\n\t\nPM11.5-80TJ265\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 265mm\n\t\nPM11.5-80TJ280\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 280mm\n\t\nPM11.5-80TJ305\tPRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 305mm\n\t\nPM13.0-80B280\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm\n\t\nPM13.0-80B305\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm\n\t\nPM13.0-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm\n\nThe Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.", "code_info": "Part Number: PM10.0-80B265\nUDI codes:\n(01)00195377150929(11)240223(17)290131(10)4021504AAA\n(01)00195377150929(11)240301(17)290228(10)4022214AAA\nLot Numbers:\n4021504AAA\n4022214AAA\t\n\nPart Number: PM10.0-80B280\nUDI codes:\n(01)00195377151032(11)240222(17)290131(10)4021505AAA\n(01)00195377151032(11)240220(17)290131(10)4021903AAA\nLot Numbers:\n4021505AAA\t\n4021903AAA\t\n\t\t\t\nPart Number: PM10.0-80B305\t\t\nUDI Codes:\n(01)00195377151148(11)240214(17)290131(10)4021217AAA\n(01)00195377151148(11)240220(17)290131(10)4021901AAA\n(01)00195377151148(11)240304(17)290228(10)4022131AAA\nLot Numbers:\n4021217AAA\t \n4021901AAA\t\n4022131AAA\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\nPM10.0-80B335\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm\t4021218AAA\t(01)00195377151254(11)240215(17)290131(10)4021218AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t4021910AAA\t(01)00195377151254(11)240221(17)290131(10)4021910AAA\n\t\t\t\n\t\t\t\n\t\t4022301AAA\t(01)00195377151254(11)240304(17)290228(10)4022301AAA\n\t\t\t\n\t\t\t\n\t\t4022625AAA\t(01)00195377151254(11)240301(17)290228(10)4022625AAA \n\t\t\t\nPM10.0-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm\t4022135AAA\t(01)00195377151360(11)240304(17)290228(10)4022135AAA\n\t\t\t\n\t\t\t\n\t\t4022136AAA\t(01)00195377151360(11)240223(17)290131(10)4022136AAA\n\t\t\t\n\t\t\t\nPM10.0-80TJ265\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm\t4021307AAA\t(01)00195377150998(11)240219(17)290131(10)4021307AAA \n\t\t\t\n\t\t\t\n\t\t4021926AAA\t(01)00195377150998(11)240221(17)290131(10)4021926AAA\n\t\t\t\n\t\t\t\nPM10.0-80TJ280\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm\t4021314AAA\t(01)00195377151100(11)240215(17)290131(10)4021314AAA\n\t\t\t\n\t\t4021602AAA\t(01)00195377151100(11)240223(17)290131(10)4021602AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t4022005AAA\t(01)00195377151100(11)240222(17)290131(10)4022005AAA\n\t\t\t\nPM10.0-80TJ305\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm\t4021401AAA\t(01)00195377151216(11)240229(17)290131(10)4021401AAA\nPM11.5-80B265\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm\t4021524AAA\t(01)00195377151698(11)240219(17)290131(10)4021524AAA\n\t\t\t\nPM11.5-80B280\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm\t4021502AAA\t(01)00195377151803(11)240216(17)290131(10)4021502AAA \n\t\t\t\n\t\t\t\n\t\t4021503AAA\t(01)00195377151803(11)240216(17)290131(10)4021503AAA\n\t\t\t\n\t\t\t\nPM11.5-80B305\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm\t4021203AAA\t(01)00195377151919(11)240215(17)290131(10)4021203AAA \n\t\t\t\n\t\t\t\n\t\t4021921AAA\t(01)00195377151919(11)240227(17)290131(10)4021921AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t4022010AAA\t(01)00195377151919(11)240301(17)290228(10)4022010AAA\n\t\t\t\n\t\t\t\n\t\t\t\nPM11.5-80B335\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm\t4021205AAA\t(01)00195377152022(11)240216(17)290131(10)4021205AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t4021530AAA\t(01)00195377152022(11)240219(17)290131(10)4021530AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t4022011AAA\t(01)00195377152022(11)240228(17)290131(10)4022011AAA\n\t\t\t\n\t\t\t\nPM11.5-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm\t4021902AAA\t(01)00195377152138(11)240222(17)290131(10)4021902AAA\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\nPM11.5-80TJ265\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm\t4021404AAA\t(01)00195377151766(11)240221(17)290131(10)4021404AAA \n\t\t\t\n\t\t\t\nPM11.5-80TJ280\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm\t4021501AAA\t(01)00195377151872(11)240219(17)290131(10)4021501AAA\n\t\t\t\n\t\t\t\n\t\t4022626AAA\t(01)00195377151872(11)240304(17)290228(10)4022626AAA\n\t\t\t\nPM11.5-80TJ305\tPRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm\t4021407AAA\t(01)00195377151988(11)240216(17)290131(10)4021407AAA\n\t\t\t\nPM13.0-80B280\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm\t4021525AAA\t(01)00195377152572(11)240220(17)290131(10)4021525AAA\n\t\t\t\n\t\t\t\n\t\t4022009AAA\t(01)00195377152572(11)240221(17)290131(10)4022009AAA \nPM13.0-80B305\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm\t4022623AAA\t(01)00195377152688(11)240301(17)290228(10)4022623AAA\n\t\t\t\nPM13.0-80B365\tPRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm\t4022001AAA\t(01)00195377152909(11)240221(17)290131(10)4022001AAA", "firm_fei_number": "3006179046", "recalling_firm": "NuVasive Specialized Orthopedics, Inc.", "address_1": "101 Enterprise Ste 100 101 Enterprise", "address_2": "Ste 100", "city": "Aliso Viejo", "state": "CA", "postal_code": "92656-2604", "additional_info_contact": "949-837-3600 Ext. 11", "reason_for_recall": "Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.", "root_cause_description": "Under Investigation by firm", "action": "On 9/30/2024, the firm sent an \"URGENT: Medical Device Recall Notification\" letter via FedEx to customers informing them that Globus Medical is investigating potential issues with the design, manufacturing, and documentation related to the validation associated with the Precice Max manufactured by NuVasive Specialized Orthopedics (NSO). \n\nCustomers are instructed to:\nMonitor their patients closely for any potential adverse events and to stop/cease use of device that have not been implanted and immediately return all remaining Precice\" Max devices and complete the attached Response Form and send it by FAX: 1-610-300-1342 or \nEmail:recall@globusmedical.com.\n\nContact Globus Customer Service at 1-866-456-2871 for Return Authorization. Contact your local Globus Sales Representative to coordinate the return of the Precice Max Device(s).\n\nFor recall related questions and support contact: Globus Medical Complaint Handling Unit by Fax: 610-300-1342 or Email: recall@globusmedical.com.", "product_quantity": "164 devices", "distribution_pattern": "U.S distribution to states of: FL and NV.", "openfda": { "k_number": [ "K013430", "K090091", "K171376", "K962552", "K983339", "K133376", "K043431", "K151062", "K191782", "K132774", "K193016", "K230071", "K041393", "K011857", "K962561", "K013449", "K253517", "K161466", "K960524", "K140601", "K083458", "K830087", "K133166", "K070761", "K043233", "K965098", "K221084", "K143204", "K120419", "K083437", "K984543", "K213328", "K860592", "K220679", "K023241", "K980102", "K143245", "K926213", "K933995", "K242247", "K081832", "K252826", "K241651", "K203399", "K984353", "K182307", "K162927", "K011622", "K130625", "K180503", "K243907", "K230512", "K191271", "K113695", "K043200", "K172943", 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