Medtronic Sofamor Danek USA Inc Recall 93163
Description: Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc Recall 93163 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0162-2024 |
| Event ID | 93163 |
| Event Description | Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix |
| Product Type | Devices |
| Distribution | US, Colombia, S. Korea, New Zealand, India, Taiwan |
| Quantity | 77 units |
| Recall 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. |
| Device Classification | 20231101 |
| Device Code Info | 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 |
| Center Classification Date | 20231024 |
| Recall Initiation Date | 20230926 |
| Recalling Firm | Medtronic Sofamor Danek USA Inc |
| Initial Notification | Letter |
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