Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE… — Class II medical device recall Z-1326-2023
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-1326-2023 |
|---|---|
| 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 | 30,541 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994961044, 00613994961051, 00613994961068, 00613994961075, 00643169122901, 00643169122918, 00643169122925, 00643169122932, 00643169430921, 00643169430938, 00643169431027, 00643169965058, 00643169965065, 00643169965072, 00643169965089 |
| Serial numbers | 34-074, 50465-054, 5177-114, 53280-057, 6-068, 9-104, A24679-096, A24679-097, A24679-098, A24679-099, A24679-100, A24679-101, A24679-102, A24679-103, A24679-104, A24679-105, A24679-106, A24679-107, A24679-108, A24679-109, A24679-110, A24679-111, A24679-112, A24679-113, A24679-114 and 475 more |
| Model numbers | 44125, 44135, 44145, 44150, T44125, T44125AUS, T44125INT, T44135, T44135INT, T44145, T44145AUS, T44145INT, T44150, T44150AUS, T44150INT |
Product
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) DBM T44135INT 15CC GRAFTON ORTHOBLEND LG, REF T44135INT; j) DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT, REF T44145; k) DBM T44145AUS 5CC GRAFTON ORTHOBLEND SM, REF T44145AUS; l) DBM T44145INT 5CC GRAFTON ORTHOBLEND SM, REF T44145INT; m) DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF, REF T44150; n) DBM T44150AUS 10CC GRAFTON ORTHOBLEND SM, REF T44150AUS; o) DBM T44150INT 10CC GRAFTON ORTHOBLEND SM, REF T44150INT; 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-1326-2023. 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.