FDA Device recall Z-0164-2024
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280 by Medtronic Sofamor Danek Usa, citing 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 requireme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0164-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
Product
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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.
Identifiers
| code_info | a) T42275: GTIN 00643169123076, Serial Numbers: A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-02…a) T42275: GTIN 00643169123076, Serial Numbers: A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-029, A58821-051, A58156-050, A59343-029, A59343-030, A59343-031, A59343-032, A59343-033, A59269-016, A59154-026, A59343-043, A59160-046, A59154-038, A59154-039, A59154-040, A59154-041, A59154-042, A58821-048, A58821-049, A59343-020, A59343-021, A59343-024, A59343-025, A59343-026, A58821-056, A58821-057, A58988-040, A59154-031, A59160-044, A58988-018, A58821-026, A58821-027, A58821-028, A58821-029, A58821-030, A58988-019, A58988-020, A58988-021, A59119-027, A58156-042, A58821-053, A58821-054, A58821-055, A58988-043, A58988-044, A58988-045, A59119-011, A59119-012, A59119-013, A59119-014, A59119-015, A59119-016, A59119-017, A59119-032, A59119-033, A59119-034, A59154-014, A59154-015, A59154-016, A59160-018, A59160-019, A59343-011, A59343-012, A59343-013, A59160-035, A59160-036, A59160-037, A58821-021, A58821-022, A58988-022, A58988-023, A58821-031, A58821-032, A58988-024, A5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0164-2024%22
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