Recall archive / FDA device enforcement

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM ... — FDA record Z-1328-2023

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. Source coverage and dates.

What the record says

Product: Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; 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: 23850 units
Agency-reported status: Ongoing
Source record identifier: Z-1328-2023

Open the official record

What the recall classes mean. 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 S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275, GTIN 00613994960931, Serial Numbers: A42914, A43126, A43182, A43185, A43460, A43613, A43715, A43896, A44262, A44388, A44561, A45997, A46401, A46690, A46699, A47001, A47719, A47942, A48136, A48371, A48792, A49045, A49089, A49108, A49790, A49952, A50039, A50528, A50688, A51827, A52539, A52601, A52788, A53401, A53671, A53788, A53881, A53904, A54204, A54988, A55032, A55132; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280, GTIN 00613994960924, Serial Numbers: A42850, A43731, A44343, A44529, A44821, A45022, A45035, A46734, A47604, A47621, A47701, A47971, A48051, A48578, A49616, A51011, A52580, A52809, A54208, A54369, A54440, A54597, A55584; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275, GTIN 00643169123076, Serial Numbers: A39563-061, A39563-062, A39563-063, A39563-064, A39563-065, A39563-066, A39563-068, A39563-070, A39563-071, A39563-072, A39563-073, A39563-074, A39563-075, A39563-076, A39563-077, A40837-011, A41106-011, A41106-012, A41106-013, A41106-014, A41106-015, A41106-016, A41106-017, A41106-018, A41106-019, A41558-011, A41558-012, A41558-013, A41558-014, A41558-015, A41558-016, A41656-011, A41656-012, A41656-013, A41656-014, A41656-015, A41656-016, A41656-017, A41656-018, A41656-019, A41656-020, A41656-021, A41656-022, A41656-023, A41656-024, A41656-025, A41656-026, A41656-027, A41656-028, A41656-029, A41656-030, A41656-031, A41656-032, A41656-033, A41656-034, A41656-035, A41656-036, A41656-037, A41656-038, A41656-039, A41656-040, A41961-011, A42020-011, A42020-012, A42020-013, A42020-014, A42020-015, A42020-016, A42020-017, A42020-018, A42020-019, A42020-020, A42020-021, A42020-022, A42020-023, A42020-024, A42020-025, A42020-026, A42020-027, A42020-028, A42085-011, A42551-011, A42551-012, A42551-013, A42551-014, A42551-015, A42551-016, A42554-011, A42554-012, A42554-013, A42554-014, A42585-011, A42585-012, A42586-011, A42586-012, A42586-013, A42586-014, A42586-015, A42586-016, A42586-017, A42586-018, A42586-019, A42586-020, A42586-021, A42586-022, A42586-023, A42586-024, A42586-025, A42586-026, A42586-027, A42586-028, A42586-029, A42586-030, A42586-031, A42596-011, A42596-012, A42596-013, A42596-014, A42596-015, A42596-016, A42596-018, A42596-019, A42596-020, A42596-021, A42596-022, A42596-023, A42596-024, A42596-025, A42596-026, A42596-027, A42596-028, A42596-029, A42596-030, A42596-031, A42596-032, A42596-033, A42634-021, A42634-022, A42634-023, A42634-024, A42634-025, A42634-026, A42634-027, A42634-028, A42634-029, A42634-030, A42634-031, A42634-032, A42634-033, A42634-034, A42634-035, A42634-036, A42634-037, A42634-038, A42634-039, A42634-040, A42635-011, A42635-012, A42635-013, A42635-014, A42635-015, A42635-016, A42635-017, A42635-018, A42635-019, A42635-020, A42635-021, A42635-022, A42635-023, A42635-024, A42635-025, A42635-026, A42635-027, A42635-028, A42635-029, A42635-030, A42635-031, A42635-032, A42635-033, A42635-034, A42635-035, A42635-036, A42635-037, A42635-038, A42648-011, A42648-012, A42648-013, A42648-014, A42648-015, A42648-016, A42648-018, A42648-019, A42648-020, A42648-021, A42648-022, A42648-023, A42648-024, A42648-025, A42648-026, A42648-027, A42648-028, A42648-029, A42648-030, A42648-031, A42671-011, A42671-012, A42680-011, A42680-012, A42683-136, A42683-137, A42683-138, A42683-139, A42683-140, A42683-141, A42683-142, A42683-143, A42683-144, A42683-145, A42683-146, A42683-147, A42683-148, A42683-149, A42683-150, A42683-151, A42683-152, A42683-153, A42683-154, A42683-155, A42683-156, A42683-157, A42815-011, A42815-012, A42815-013, A42815-014, A42815-015, A42815-016, A42815-017, A42815-018, A42815-019, A42815-020, A42815-021, A42815-022, A42815-023, A42815-024, A42815-025, A42815-026, A42815-027, A42815-028, A42815-029, A42815-030, A42844-011, A42844-012, A42844-013, A42851-011, A42851-012, A42851-013, A42851-014, A42851-015, A42851-016, A42851-017, A42851-018, A42851-019, A42851-020, 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A43601-020, A43601-021, A43601-022, A43601-023, A43601-024, A43601-025, A43601-026, A43601-027, A43601-028, A43601-029, A43601-030, A43601-031, A43601-032, A43601-033, A43601-034, A43601-035, A43601-036, A43601-037, A43603-011, A43603-012, A43603-013, A43603-014, A43603-015, A43603-016, A43603-017, A43603-018, A43603-019, A43603-020, A43603-021, A43603-022, A43603-023, A43603-024, A43603-025, A43603-026, A43603-027, A43603-028, A43603-029, A43603-030, A43603-031, A43665-011, A43665-012, A43665-013, A43665-014, A43665-015, A43665-016, A43666-032, A43666-033, A43666-034, A43704-011, A43704-012, A43704-013, A43720-011, A43720-012, A43720-013, A43720-014, A43720-015, A43720-016, A43720-017, A43720-018, A43720-019, A43720-020, A43720-021, A43720-022, A43720-023, A43720-024, A43720-025, A43720-026, A43720-027, A43720-028, A43720-029, A43720-030, A43720-031, A43720-032, A43720-033, A43720-034, A43732-011, A43732-012, A43732-013, A43763-011, A43763-012, A43782-011, A43782-012, A43782-013, A43782-014, A43782-015, A43782-016, A43782-017, A43782-018, A43782-019, A43782-020, A43782-021, A43782-022, A43782-023, A43782-024, A43782-025, A43782-026, A43782-027, A43782-028, A43782-029, A43782-030, A43782-031, A43784-011, A43784-012, A43784-013, A43816-011, A43816-012, A43816-013, A43816-014, A43816-015, A43816-016, A43816-017, A43816-018, A43816-019, A43816-020, A43816-021, A43816-022, A43816-023, A43816-024, A43816-025, A43816-026, A43816-027, A43816-028, A43816-029, A43816-030, A43816-031, A43816-032, A43816-033, A43816-034, A43816-035, A43816-037, A43816-038, A43816-039, A43816-040, A43816-041, A43816-042, A43816-043, A43816-044, A43839-011, A43839-012, A43839-013, A43839-014, A43839-015, A43839-016, A43839-017, A43839-018, A43839-019, A43839-020, A43839-021, A43839-022, A43839-023, A43839-024, A43839-025, A43839-026, A43839-027, A43839-028, A43839-029, A43839-030, A43839-031, A43839-032, A43839-033, A43839-034, A43839-035, A43841-011, A43841-012, A43841-013, A43841-014, 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A44182-019, A44182-020, A44182-021, A44182-022, A44182-023, A44182-024, A44182-025, A44182-026, A44182-027, A44221-071, A44221-072, A44226-011, A44226-012, A44226-013, A44226-014, A44226-015, A44226-016, A44226-017, A44226-018, A44226-019, A44226-020, A44226-021, A44226-022, A44226-023, A44226-024, A44226-025, A44226-026, A44226-027, A44226-028, A44226-029, A44244-011, A44244-012, A44244-013, A44244-014, A44244-015, A44255-011, A44255-012, A44255-013, A44255-014, A44255-015, A44255-016, A44255-017, A44255-018, A44255-019, A44255-020, A44255-021, A44255-022, A44255-023, A44255-024, A44255-025, A44255-026, A44255-027, A44255-028, A44255-029, A44255-030, A44255-031, A44255-032, A44255-033, A44255-034, A44255-035, A44255-036, A44255-037, A44255-038, A44255-039, A44255-040, A44255-041, A44255-042, A44255-043, A44261-011, A44261-012, A44261-013, A44261-014, A44261-015, A44261-016, A44261-017, A44301-011, A44310-011, A44310-012, A44310-013, A44310-014, A44310-015, A44310-016, A44310-017, 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A44337-013, A44337-014, A44337-015, A44337-016, A44337-017, A44337-018, ...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275, GTIN 00613994960931, Serial Numbers: A42914, A43126, A43182, A43185, A43460, A43613, A43715, A43896, A44262, A44388, A44561, A45997, A46401, A46690, A46699, A47001, A47719, A47942, A48136, A48371, A48792, A49045, A49089, A49108, A49790, A49952, A50039, A50528, A50688, A51827, A52539, A52601, A52788, A53401, A53671, A53788, A53881, A53904, A54204, A54988, A55032, A55132; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280, GTIN 00613994960924, Serial Numbers: A42850, A43731, A44343, A44529, A44821, A45022, A45035, A46734, A47604, A47621, A47701, A47971, A48051, A48578, A49616, A51011, A52580, A52809, A54208, A54369, A54440, A54597, A55584; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275, GTIN 00643169123076, Serial Numbers: A39563-061, A39563-062, A39563-063, A39563-064, A39563-065, A39563-066, A39563-068, A39563-070, A39563-071, A39563-072, A39563-073, A39563-074, A39563-075, A39563-076, A39563-077, A40837-011, 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A44337-015, A44337-016, A44337-017, A44337-018, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

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