--- title: "Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S4... — FDA record Z-1327-2023 | Is It on Recall" description: "Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in" url: https://isitonrecall.com/recall/fda-device-z-1327-2023-medtronic-grafton-matrix-a-dbm-s42200-grafton-2-5cmx10cm-2ea-matrix-ref-s42200-b-dbm-s42210-grafton/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2E... — FDA record Z-1327-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Feb 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product - **Reason**: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. - **Classification**: Class II - **Recalling firm**: Medtronic Sofamor Danek USA Inc - **Quantity**: 19057 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1327-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1327-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693, A42811, A43336, A43592, A44884, A44960; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210, GTIN 00613994960948, Serial Numbers: A42415, A42482, A42953, A43212, A43354, A43965, A44760, A45028, A46673, A48105, A48484, A49062, A49564, A50856, A52420, A52719, A52904, A53373; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200, GTIN 00643169123052, Serial Numbers: A38910-046, A38910-047, A38910-048, A38910-049, A38910-050, A38910-051, A38910-052, A38910-053, A38910-054, A38910-055, A38910-056, A38910-057, A39374-061, A39374-062, A39374-063, A39374-064, A39374-065, A39374-066, A39374-067, A39374-068, A39374-069, A39374-070, A39374-071, A39374-072, A39736-021, A39736-022, A39736-023, A39736-024, A39736-025, A39736-026, A39736-027, A39736-028, A39736-029, A39736-030, A39736-031, A39736-032, A39803-051, A39803-052, A39803-053, A39803-054, A39803-055, A39803-056, A39803-057, A39803-058, A39803-059, A39803-060, A39803-061, A39803-062, A40169-050, A40169-051, A40169-052, A40169-053, A40169-054, A40169-055, A40169-056, A40169-057, A40327-056, A40327-057, A40327-058, A40327-059, A40327-060, A40327-061, A40327-062, A40327-063, A40656-036, A40656-037, A40656-038, A40656-039, A40656-040, A40656-042, A40656-043, A40656-044, A40656-045, A40656-046, A40656-047, A40710-051, A40710-052, A40710-053, A40710-054, A40710-055, A40710-056, A40710-057, A40710-058, A40710-059, A40710-060, A40710-061, A40710-062, A40752-041, A40752-042, A40752-043, A40752-044, A40752-045, A40752-046, A40752-047, A40752-048, A40752-049, A40752-050, A40752-051, A40752-052, A40821-056, A40821-057, A40821-058, A40821-059, A40821-060, A40821-061, A40821-062, A40821-063, A40821-064, A40868-011, A40868-012, A40868-013, A40868-014, A40868-015, A40868-016, A40868-017, A40868-018, A40868-019, A40868-020, A40868-021, A40868-022, A40984-011, A40984-012, A40984-013, A40984-014, A40984-015, A40984-016, A40984-017, A40984-018, A40984-019, A41004-041, A41004-042, A41004-043, A41004-044, A41004-045, A41004-046, A41004-047, A41004-048, A41004-049, A41008-127, A41008-128, A41008-129, A41008-130, A41008-131, A41211-021, A41211-022, A41211-023, A41211-024, A41211-025, A41211-026, A41211-027, A41211-028, A41211-029, A41211-030, A41211-031, A41211-032, A41214-041, A41214-042, A41214-043, A41214-044, A41214-045, A41214-046, A41214-047, A41214-048, A41214-049, A41214-050, A41214-051, A41233-011, A41233-012, A41233-013, A41233-014, A41233-015, A41233-016, A41233-017, A41233-018, A41233-019, A41233-020, A41233-021, A41233-022, A41312-031, A41312-032, A41312-033, A41312-034, A41312-035, A41312-036, A41312-037, A41312-038, A41312-039, A41312-040, A41312-041, A41313-041, A41313-042, A41313-043, A41313-044, A41313-045, A41313-046, A41313-047, A41313-048, A41313-049, A41313-050, A41383-022, A41383-023, A41383-024, A41383-025, A41383-026, A41383-027, A41383-028, A41383-029, A41383-030, A41383-031, A41383-032, A41383-033, A41640-011, A41640-012, A41640-013, A41640-014, A41640-015, A41640-016, A41640-017, A41640-018, A41640-019, A41648-031, A41648-032, A41648-033, A41648-034, A41648-035, A41648-036, A41648-037, A41648-038, A41648-039, A41648-040, A41648-041, A41648-042, A41683-011, A41683-012, A41683-013, A41683-014, A41683-015, A41683-016, A41683-017, A41683-018, A41683-019, A41683-020, A41683-021, A41785-059, A41785-060, A41785-061, A41785-062, A41785-063, A41785-064, A41785-065, A41785-066, A41785-067, A41785-068, A41785-069, A41971-011, A41971-012, A41971-013, A41971-014, A41971-015, A41971-016, A41971-017, A41971-018, A41971-019, A42098-011, A42098-012, A42098-013, A42098-014, A42098-015, A42098-016, A42098-017, A42098-018, A42098-019, A42245-031, A42245-032, A42245-033, A42245-034, A42245-035, A42245-036, A42245-037, A42245-038, A42245-039, A42245-040, A42245-041, A42245-042, A42305-011, A42305-012, A42305-013, A42305-014, A42305-015, A42305-016, A42305-017, A42305-018, A42305-019, A42305-020, A42305-021, A42305-022, A42305-023, A42305-024, A42457-011, A42457-012, A42457-013, A42457-014, A42457-015, A42457-016, A42457-017, A42457-018, A42457-019, A42457-020, A42457-021, A42469-011, A42469-012, A42469-013, A42469-014, A42469-015, A42469-016, A42469-017, A42469-018, A42469-020, A42469-021, A42469-022, A42480-011, A42480-012, A42480-013, A42480-014, A42480-015, A42480-016, A42480-017, A42480-018, A42480-019, A42543-011, A42543-012, A42543-013, A42543-014, A42543-015, A42543-016, A42543-017, A42543-018, A42543-019, A42543-020, A42543-021, A42590-011, A42590-012, A42590-013, A42590-014, A42590-015, A42590-016, A42590-017, A42590-018, A42590-019, A42590-020, A42590-021, A42590-022, A42603-021, A42603-022, A42603-023, A42603-024, A42603-025, A42603-026, A42603-027, A42603-028, A42603-029, A42603-030, A42603-031, A42622-051, A42622-052, A42622-053, A42622-054, A42622-055, A42622-056, A42622-057, A42622-058, A42622-059, A42622-060, A42622-061, A42626-011, A42626-012, A42626-013, A42626-014, A42626-015, A42626-016, A42626-017, A42626-018, A42626-019, A42626-020, A42626-021, A42626-022, A42646-021, A42646-022, A42646-023, A42646-024, A42646-025, A42646-026, A42646-027, A42646-028, A42646-029, A42646-030, A42675-011, A42675-012, A42675-013, A42675-014, A42675-015, A42675-016, A42675-017, A42675-018, A42675-019, A42675-020, A42675-021, A42686-011, A42686-012, A42686-013, A42686-014, A42686-015, A42686-016, A42686-017, A42686-018, A42688-011, A42688-012, A42688-013, A42688-014, A42688-015, A42688-016, A42688-017, A42688-018, A42688-019, A42688-020, A42688-021, A42688-022, A42693-011, A42693-012, A42693-013, A42693-014, A42693-015, A42693-016, A42693-017, A42693-018, A42693-019, A42693-020, A42693-021, A42693-022, A42696-011, A42696-012, A42696-013, A42696-014, A42696-015, A42696-016, A42696-017, A42696-018, A42696-019, A42696-020, A42696-021, A42696-022, A42749-011, A42749-012, A42749-013, A42749-014, A42749-015, A42749-016, A42749-017, A42749-018, A42749-019, A42749-020, A42749-021, A42765-011, A42765-012, A42765-013, A42765-014, A42765-015, A42765-016, A42765-017, A42765-018, A42767-011, A42767-012, A42767-013, A42767-014, A42767-015, A42767-016, A42767-017, A42767-018, A42774-011, A42774-012, A42774-013, A42774-014, A42774-015, A42774-016, A42774-017, A42774-018, A42774-019, A42774-020, A42774-021, A42776-011, A42776-012, A42776-013, A42776-014, A42776-015, A42776-016, A42776-017, A42776-018, A42803-011, A42803-012, A42803-013, A42803-014, A42803-015, A42803-016, A42803-017, A42803-018, A42803-019, A42811-011, A42811-012, A42811-013, A42811-014, A42811-015, A42811-016, A42811-017, A42818-011, A42818-012, A42818-013, A42818-014, A42818-015, A42818-016, A42818-017, A42818-018, A42818-019, A42818-020, A42818-021, A42818-022, A42837-011, A42837-012, A42837-013, A42837-014, A42837-015, A42837-016, A42837-017, A42837-018, A42837-019, A42837-020, A42837-021, A42837-022, A42838-011, A42838-012, A42838-013, A42838-014, A42838-015, A42838-016, A42838-017, A42838-018, A42838-019, A42841-011, A42841-012, A42841-013, A42841-014, A42841-015, A42841-016, A42841-017, A42841-018, A42841-019, A42841-020, A42841-021, A42841-022, A42856-011, A42856-012, A42856-013, A42856-014, A42856-015, A42856-016, A42856-017, A42856-018, A42856-019, A42856-020, A42898-011, A42898-012, A42898-013, A42898-014, A42898-015, A42898-016, A42898-017, A42898-018, A42898-019, A42898-020, A42898-021, A42898-022, A42910-011, A42910-012, A42910-013, A42910-014, A42910-015, A42910-016, A42910-017, A42910-018, A42910-019, A42910-020, A42910-021, A42910-022, A42951-011, A42951-012, A42951-013, A42951-014, A42951-015, A42951-016, A42951-017, A42951-018, A42951-019, A42962-031, A42962-032, A42962-033, A42962-034, A42962-035, A42962-036, A42962-037, A42962-038, A42962-039, A42962-040, A42962-041, A42962-042, A42968-031, A42968-032, A42968-033, A42968-034, A42968-035, A42968-036, A42968-037, A42968-038, A42968-039, A42968-040, A42992-011, A42992-012, A42992-013, A42992-014, A42992-016, A42992-017, A42992-018, A42992-019, A42993-011, A42993-012, A42993-013, A42993-014, A42993-015, A42993-016, A42993-017, A42993-018, A42993-019, A42993-020, A42993-021, A42993-022, A42993-023, A42993-024, A42994-011, A42994-012, A42994-013, A42994-014, A42994-015, A42994-016, A42994-017, A42994-018, A42994-019, A42994-020, A42996-011, A42996-012, A42996-013, A42996-014, A42996-015, A42996-016, A42996-017, A42996-018, A42996-019, A42997-011, A42997-012, A42997-013, A42997-014, A42997-015, A42997-016, A42997-018, A42997-019, A42997-020, A43042-011, A43042-012, A43042-013, A43042-014, A43042-015, A43042-016, A43042-017, A43042-018, A43042-019, A43087-011, A43087-012, A43087-013, A43087-014, A43087-015, A43087-016, A43087-017, A43087-018, A43087-019, A43087-020, A43087-021, A43087-022, A43116-056, A43116-057, A43116-058, A43116-059, A43116-060, A43116-061, A43116-062, A43116-063, A43116-064, A43130-023, A43130-024, A43130-025, A43130-026, A43130-027, A43130-028, A43130-029, A43130-030, A43130-031, A43130-032, A43130-033, A43145-011, A43145-012, A43145-013, A43145-014, A43145-015, A43145-016, A43145-017, A43145-018, A43145-019, A43145-020, A43145-021, A43156-025, A43156-026, A43156-027, A43156-028, A43156-029, A43156-030, A43156-031, A43156-032, A43156-033, A43176-011, A43176-012, A43176-013, A43176-014, A43176-015, A43176-016, A43176-017, A43176-018, A43176-019, A43176-020, A43176-021, A43202-019, A43202-020, A43202-021, A43202-022, A43227-011, A43227-012, A43227-013, A43227-014, A43227-015, A43227-016, A43227-017, A43227-018, A43227-019, A43227-020, A43237-011, A43237-012, A43237-013, A43237-014, A43237-015, A43237-016, A43238-011, A43238-012, A43238-013, A43238-014, A43238-015, A43238-016, A43238-017, A43238-018, A43238-019, A43238-020, A43238-021, A43270-011, A43270-012, A43270-013, A43270-014, A43270-015, A43270-016, A43270-017, A43270-018, A43270-019, A43270-020, A43270-021, A43279-011, A43279-012, A43279-013, A43279-014, A43279-016, A43279-017, A43279-018, A43295-042, A43295-043, A43295-044, A43295-045, A43295-046, A43295-047, A43295-048, A43295-049, A43308-011, A43308-012, A43308-013, A43308-014, A43308-015, A43308-016, A43308-017, A43308-018, A43308-019, A43308-020, A43314-011, A43314-012, A43314-013, A43314-014, A43314-015, A43314-016, A43314-017, A43314-018, A43314-019, A43314-020, A43314-021, A43319-011, A43319-012, A43319-013, A43319-014, A43319-015, A43319-016, A43319-017, A43319-018, A43319-019, A43319-020, A43319-021, A43319-022, A43323-011, A43323-012, A43323-013, A43323-014, A43323-015, A43323-016, A43323-017, A43323-018, A43323-019, A43332-036, A43332-037, A43332-038, A43332-039, A43332-040, A43332-041, A43332-042, A43332-043, A43332-044, A43332-045, A43332-046, A43332-047, A43332-048, A43332-049, A43336-036, A43336-037, A43336-038, A43336-039, A43350-011, A43350-012, A43350-013, A43350-014, A43350-015, A43350-016, A43350-017, A43350-018, A43394-066, A43394-067, A43394-068, A43394-069, A43394-070, A43394-071, A43394-072, A43394-073, A43394-074, A43394-075, A43394-076, A43394-077, A43394-078, A43404-011, A43404-012, A43404-013, A43404-014, A43404-015, A43404-016, A43404-017, A43404-018, A43404-019, A43404-020, A43411-011, A43411-012, A43411-013, A43411-014, A43411-015, A43411-016, A43411-017, A43423-011, A43423-012, A43423-013, A43423-014, A43423-015, A43423-016, A43423-017, A43512-011, A43512-012, A43512-013, A43512-014, A43512-015, A43521-011, A43521-012, A43521-013, A43521-014, A43521-015, A43521-016, A43521-017, A43521-018, A43521-019, A43521-020, A43521-021, A43521-022, A43521-023, A43521-024, A43522-011, A43522-012, A43522-013, A43522-014, A43522-015, A43522-016, A43522-017, A43522-018, A43533-011, A43533-012, A43533-013, A43533-014, A43533-015, A43533-016, A43533-017, A43533-018, A43533-019, A43533-020, A43556-011, A43556-012, A43556-013, A43556-014, A43556-015, A43556-016, A43556-017, A43556-018, A43556-019, A43556-020, A43556-021, A43556-022, A43556-023, A43563-011, A43563-012, ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1327-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Apr 12, 2023 - **Recall initiation date**: Feb 8, 2023 - **Center classification date**: Apr 4, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1327-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Sofamor Danek USA Inc records](https://isitonrecall.com/brand/medtronic-sofamor-danek-usa-inc/)