Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2 — Class II medical device recall Z-1327-2023
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-1327-2023 |
|---|---|
| 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 | 19,057 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994960948, 00613994960955, 00643169123052, 00643169123069, 00643169431034, 00643169431041, 00643169964914, 00643169964921, 00763000191689, 00763000191696 |
| Serial numbers | 016, 9642-090, A37471-031, A37471-032, A37471-033, A37471-034, A37471-035, A37471-036, A37471-037, A37471-038, A37471-039, A37471-040, A37471-041, A37471-042, A37471-043, A37471-044, A37471-045, A37471-046, A37471-047, A37471-048, A37471-049, A38910-046, A38910-047, A38910-048, A38910-049 and 475 more |
| Model numbers | 42200, 42210, T42200, T42200AUS, T42200INT, T42200JPN, T42210, T42210AUS, T42210INT, T42210JPN |
Product
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; 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-1327-2023. 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.