Grafton DBM Orthoblend — Class II medical device recall Z-0165-2024
Ongoing recall by Medtronic Sofamor Danek USA Inc, reported 2023-11-01. Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the
| Recall number | Z-0165-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2023-09-26 |
| Classified | 2023-10-24 |
| Reported by FDA | 2023-11-01 |
| Countries outside the US | CO, IN, KR, NZ, TW |
| Quantity | 430 units |
| UPC / GTIN / UDI-DI | 00643169122918, 00643169122925, 00643169122932, 00643169965058 |
| Serial numbers | A47028-036, A47028-037, A47028-038, A47028-039, A47028-040, A47028-041, A47028-042, A47028-043, A47028-044, A47028-045, A47028-046, A47028-047, A47028-048, A47028-049, A47028-050, A47028-051, A47028-052, A47028-053, A47028-054, A47028-055, A47028-056, A47028-057, A47028-058, A47028-059, A47028-065 and 405 more |
Product
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0165-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.