Recall archive / FDA device enforcement
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix — FDA record Z-0162-2024
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 Sep 26, 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
- Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 77 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0162-2024
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 | GTIN 00643169123007, Serial Numbers: A57164-040, A58820-011, A57164-041, A57164-042, A59190-046, A59190-041, A59190-042, A59190-043, A59190-044, A59190-045, A57164-026, A57164-027, A57164-028, A57164-029, A57164-030, A57164-031, A57164-032, A57164-033, A58820-017, A58820-018, A57164-011, A57164-012, A57164-013, A57164-014, A57164-015, A57164-016, A57164-017, A57164-018, A57164-019, A57164-020, A57164-021, A57164-022, A57164-023, A57164-024, A57164-025, A57164-034, A57164-035, A57164-036, A57164-037, A57164-038, A57164-039, A58820-012, A58820-013, A58820-014, A58820-015, A58820-016, A58820-019, A58820-020, A58820-021, A58820-022, A58820-023, A58820-024, A58820-025, A58820-026, A58820-027, A58820-028, A58820-029, A58820-030, A58820-031, A58820-033, A58820-034, A58820-035, A58820-036, A58820-037, A58820-038, A58820-039, A58820-040, A59190-031, A59190-032, A59190-033, A59190-034, A59190-035, A59190-036, A59190-037, A59190-038, A59190-039, A59190-040 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Colombia, S. Korea, New Zealand, India, Taiwan
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 1, 2023
- Recall initiation date
- Sep 26, 2023
- Center classification date
- Oct 24, 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.