INFUSE Bone Graft X SMALL KIT REF 7510100 — Class II medical device recall Z-0440-2019
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2018-11-21. The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS),
| Recall number | Z-0440-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2018-09-27 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-09-16 |
| Quantity | 138 units |
| UPC / GTIN / UDI-DI | 00613994239525 |
| Lot numbers | M111806AAA |
| Model numbers | 7510100 |
Product
INFUSE Bone Graft X SMALL KIT REF 7510100
Reason for recall
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
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-0440-2019. 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.