Grafton DBM Crunch — Class II medical device recall Z-0161-2024
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-0161-2024 |
|---|---|
| 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 | 84 units |
| UPC / GTIN / UDI-DI | 00643169123113 |
| Serial numbers | A56737-049, A56737-050, A56737-051, A56737-052, A56737-053, A56737-054, A56737-055, A56737-056, A56737-057, A56737-058, A56737-059, A56737-060, A56737-061, A56737-062, A56737-063, A56858-021, A56858-022, A56858-023, A56858-024, A56858-025, A56858-026, A56858-027, A56858-028, A56858-029, A56858-030 and 59 more |
| Model numbers | T44115 |
Product
Grafton DBM Crunch, Model Numbers: T44115, 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-0161-2024. 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.