Grafton DBM Matrix Strips — Class II medical device recall Z-0164-2024
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-0164-2024 |
|---|---|
| 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 | 282 units |
| UPC / GTIN / UDI-DI | 00643169123076, 00643169123083 |
| Serial numbers | A57660-011, A57660-012, A57660-013, A57660-014, A57660-015, A57660-016, A57660-017, A57660-018, A57660-019, A57660-020, A57660-021, A58085-011, A58156-032, A58156-035, A58156-042, A58156-043, A58156-045, A58156-046, A58156-047, A58156-048, A58156-049, A58156-050, A58156-051, A58156-052, A58264-011 and 257 more |
Product
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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-0164-2024. 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.