Grafton Plus DBM Paste — Class II medical device recall Z-0166-2024
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-0166-2024 |
|---|---|
| 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 | 583 units |
| UPC / GTIN / UDI-DI | 00643169122949, 00643169123021, 00643169123038 |
| Serial numbers | A48245-018, A48245-019, A48245-020, A48245-021, A48245-022, A48245-023, A48245-024, A48245-025, A48245-026, A48245-027, A48245-028, A48245-029, A48245-030, A48245-031, A48245-032, A48245-033, A48245-034, A48245-035, A48245-036, A48245-037, A48245-038, A48245-039, A48245-040, A48245-041, A48245-042 and 475 more |
Product
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; 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-0166-2024. 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.