Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC — Class II medical device recall Z-1331-2023
Ongoing recall by Medtronic Sofamor Danek USA Inc, reported 2023-04-12, distributed nationwide. Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system.
| Recall number | Z-1331-2023 |
|---|---|
| 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 | 2023-02-08 |
| Classified | 2023-04-04 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CL, CO, DK, DO, EC, ES, FI, GB, GH, GR, GT, HK, IE, IL, IN, JM, JO, JP, KR, KW, LB, LU, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PT, PY, SA, SG, TH, TT, TW, VN, ZA |
| Quantity | 10,037 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00763000254001, 00763000254018, 00763000254025 |
| Serial numbers | A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020 and 475 more |
| Model numbers | T50303, T50306, T50309 |
Product
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
Reason for recall
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
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-1331-2023. 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.