Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH — Class II medical device recall Z-1324-2023
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-1324-2023 |
|---|---|
| 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 | 5,308 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994961082, 00613994961099, 00643169123113, 00643169123120, 00643169965034, 00643169965041 |
| Serial numbers | A26631-051, A26631-052, A26631-053, A26631-054, A26631-055, A26631-056, A26631-057, A38377-125, A38377-126, A38377-127, A38377-128, A38377-129, A38377-130, A38377-131, A38377-132, A38377-133, A38471-041, A38471-042, A38471-043, A38471-044, A38471-045, A38471-046, A38471-047, A38472-047, A38472-048 and 475 more |
| Model numbers | 44105, 44115, T44105, T44105INT, T44115, T44115INT |
Product
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; 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-1324-2023. 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.