{ "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": "203586", "product_res_number": "Z-0163-2024", "event_date_initiated": "2023-09-26", "event_date_posted": "2023-10-25", "recall_status": "Open, Classified", "res_event_number": "93163", "product_code": "MBP", "k_numbers": [ "K051195" ], "product_description": "Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix", "code_info": "a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012; \n\nb) T42210: GTIN 00643169123069, Serial Numbers: A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039, A57362-018, A58518-032, A58518-033, A58518-034, A58133-031, A58518-028, A59200-023, A59200-024, A57362-020, A57362-021, A57362-022, A58122-024, A58122-025, A58518-026, A58545-021, A59200-025, A59200-026, A58545-019, A58545-020, A58133-032, A58133-033, A58133-035, A58518-027, A59200-027, A58133-034, A59122-014, A57344-011, A57344-012, A57344-014, A57344-015, A57344-016, A59200-028, A58545-025, A58545-026, A58545-027, A58518-030, A58133-037, A58133-038, A58518-029, A59122-015, A59122-016, A57387-025, A57362-023, A57362-024, A57362-025, A58122-026, A58122-027, A58122-028, A58122-029, A59122-011, A59122-012, A59122-013", "firm_fei_number": "1000477302", "recalling_firm": "Medtronic Sofamor Danek USA Inc", "address_1": "1800 Pyramid Pl", "city": "Memphis", "state": "TN", "postal_code": "38132-1703", "reason_for_recall": "Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.", "root_cause_description": "Employee error", "action": "Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices.", "product_quantity": "377 units", "distribution_pattern": "US, Colombia, S. Korea, New Zealand, India, Taiwan", "openfda": { "k_number": [ "K060180", "K042829", "K080405", "K242799", "K130703", "K060161", "K050642", "K063676", "K063685", "K103742", "K081817", "K053098", "K113728", "K080399", "K122513", "K061982", "K053642", "K052735", "K061131", "K043048", "K091193", "K051195", "K043209", "K061668", "K143547", "K073329", "K050806", "K080329", "K130498", "K062205", "K060794" ], "registration_number": [ "1038671", "2245304", "3008522639", "2030598", "2011171", "1226544", "1032347", "1000307092", "3000215346", "3016851379", "3008812241", "3010560653", "3008650117", "2090010", "3012102437", "3018094310", "3002719998", "2029275", "3005381997", "3016050940", "1222747", "3009672666", "1225112", "3010376334", "3012161787", "1319660", "1216032", "3012448339", "3014211822", "3003477135", "3010667733", "3014078231", "2031966", "1424263", "2249915", "1825034", "3015724777", "2024024", "3015231789", "1220477", "3010331645", "2249062", "1450662", "1043534", "3009144915", "1030489", "3009882464", "1220246", "3012447612", "3003828812", "3005064037", "3005031160" ], "fei_number": [ "1038671", "3003128516", "2245304", "3008522639", "3002980729", "2011171", "1032347", "1000307092", "3000215346", "3016851379", "3010560653", "3008650117", "3012102437", "3002719998", "3018094310", "3010501626", "3005381997", "3016050940", "1000306431", "3009672666", "3014298539", "3012161787", "1000477302", "1216032", "3002600221", "3012448339", "3003477135", "3003015552", "3001503333", "3010667733", "3014078231", "1825034", "3001236616", "2024024", "3015724777", "3015231789", "1220477", "3010331645", "1000518731", "1450662", "1000120776", "1043534", "3009144915", "1000136478", "3006813973", "3000206397", "3009882464", "1220246", "3012447612", "3003828812", "3005064037", "3005031160" ], "device_name": "Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3045", "device_class": "2" } } ] }