Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE — Class II medical device recall Z-1329-2023
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-1329-2023 |
|---|---|
| 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 | 37,721 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994961013, 00613994961020, 00613994961037, 00643169122949, 00643169123021, 00643169123038, 00643169431003, 00643169431058, 00643169965096, 00643169965102, 00643169965119 |
| Serial numbers | 025, 028, 037, 6150-013, 997-063, A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, A24679-164, A24679-165, A24679-166, A24679-167, A24679-168, A24679-169, A24679-170, A24679-171, A24679-172, A24679-173, A24679-176, A24679-177 and 475 more |
| Model numbers | 45001, 45005, 45010, T45001, T45001AUS, T45001INT, T45005, T45005INT, T45010, T45010AUS, T45010INT |
Product
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; 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-1329-2023. 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.