FDA Device recall Z-0165-2024
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150 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-0165-2024 |
| 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 Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; 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) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559…a) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559-041, A52559-044, A52559-045, A52559-021, A52559-022, A52559-023, A52559-025, A52559-026, A52559-027, A52559-028, A52559-029, A52559-030, A52559-031, A52559-032, A52559-033, A52559-034, A52559-035, A52559-036, A52559-037, A52559-043; b) T44135: GTIN 00643169122918, Serial Numbers: A59102-034, A59102-035, A58789-025, A58789-026, A58789-027, A59080-036, A59080-037, A58789-030, A58789-031, A58789-032, A58789-033, A58789-034, A58789-035, A58789-036, A58789-037, A58789-038, A58789-039, A59102-042, A59102-043, A59102-044, A59102-045, A59102-046, A59102-047, A59102-048, A59102-049, A59102-050, A59102-051, A59103-030, A59103-031, A59103-032, A59103-033, A59103-034, A59103-035, A59103-036, A59103-037, A59103-038, A59103-039, A59102-055, A59102-056, A58789-061, A58789-062, A59080-022, A59080-026, A59080-027, A59080-028, A59080-029, A59080-030, A59102-038, A59102-039, A59102 |
|---|
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-0165-2024%22
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