{ "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": "197007", "product_res_number": "Z-0692-2023", "event_date_initiated": "2022-11-03", "event_date_posted": "2022-12-15", "recall_status": "Open, Classified", "res_event_number": "91134", "product_code": "LRO", "product_description": "DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01", "code_info": "Lot Numbers: Lot 56190288 exp 8/1/2023; Lot 56224943 exp 8/1/2023; Lot 56432718 exp 2/1/2023; Lot 56432726 exp 8/1/2023; Lot 56639065 exp 8/1/2023; Lot 56906961 exp 8/1/2023; Lot 57051271 exp 8/1/2023; Lot 57228161 exp 8/1/2023; Lot 57393491 exp 1/1/2024; Lot 57488967 exp 3/1/2024; Lot 57679350 exp 3/1/2024; Lot 57685371 exp 3/1/2024; Lot 57751551 exp 3/1/2024", "firm_fei_number": "1043214", "recalling_firm": "DeRoyal Industries Inc", "address_1": "200 Debusk Ln", "city": "Powell", "state": "TN", "postal_code": "37849-4703", "additional_info_contact": "Theresa Marsee\n865-938-7828", "reason_for_recall": "XXX", "root_cause_description": "Nonconforming Material/Component", "action": "The firm issued an URGENT RECALL NOTICE to its consignees on 11/03/2022 by email and US mail. \n1) Using the attached Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use.\n2) DeRoyal will contact you to schedule time to affix labels to all affected product. These labels indicate that, at the time of use, the affected product should be removed from the kit/tray and destroyed. These products should be destroyed according to your facility, local, state and federal regulations.\n3) DeRoyal representative will determine kits/trays and affected lot numbers which require the labeling indicating to remove 3M Health Care item.\n4) The completed the NOTICE OF DESTRUCTION FORM shall be emailed to recalls@deroyal.com no later than 12/8/2022. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY.\n5) The remaining items in the kit/tray are unaffected and may still be used.\n\n\nDistributors were asked to perform the following: \n\"1) Using the attached Distributor Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and request placement in quarantine to prevent further use.\n2) Please notify us with the quantity of affected cases, product and lot numbers in your inventory to which labels will need to be applied. Email this to recalls@deroyal.com no later than 11/21/2022. We will immediately send labeling for you to apply to case and each pack contained within.\n3) These labels indicate that, at the time of use, the affected product should be removed from the kit / tray and destroyed.\n4) The remaining items in the kit/tray are unaffected and may still be used.\n5) If you have questions or need assistance with the recall, please contact your DeRoyal Supplier Relations contact, customer service at 888.938.7828, or email us at recalls@deroyal.com.", "product_quantity": "1196 kits", "distribution_pattern": "US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi", "openfda": { "k_number": [ "K854292", "K871459", "K871322", "K930700", "K945481", "K963443", "K951149", "K895202", "K926269", "K905459", "K925016", "K935743", "K914174", "K920292", "K931673", "K931844", 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"K931758", "K885090", "K890570" ], "registration_number": [ "3005595283", "1650907", "3044906632", "3015895045", "3030078769", "3005997949", "8022032", "1824619", "3011144486", "1527607", "3011500469", "3016096096", "3042480961", "3043620414", "1018470", "3007007790", "3003495693", "3012811961", "3004911384", "3002806603", "9611594", "3010452421", "3015960676", "2433012", "3006846316", "3007082897", "1420054", "1823410", "3011270181", "3014680744", "3007829657", "2011171", "2029015", "3010166880", "3018077422", "1526711", "1424263", "1928237", "3011494917", "3036002406", "3011554160", "3013960812", "3007289408", "3004605321", "3016761372", "3018116884", "8030678", "8030672", "1061124", "3041276890", "3006973666", "3006542380", "3010376936", "3009637528", "1921846", "3045857302", "3006191977", "3013298431", "3014325891", "3009773841", "2936485", "3013600605", "3017430544", "8022210", "1063382", "1030451", "3007329020", "3013466775", "3004111573", "3023140882", "9680357", "3008496560", 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"3007344957", "2024311", "3003015552", "3013502418", "3019798849", "3002807170", "3017467279", "3018071447", "3194", "3008403546", "3014704068", "3013421458", "3004122598", "3002806436", "3002902735", "3000215259", "3013735189", "3000717925", "3008373372", "3009750712", "3009888344", "1047429", "3004713352", "1643817", "3005669815", "3027977504", "3003924117", "3003040625" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }