Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC — Class II medical device recall Z-1333-2023
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-1333-2023 |
|---|---|
| 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 | 10,090 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994961143, 00613994961167, 00643169122956, 00643169122963, 00643169122970, 00643169122987, 00643169964839, 00643169964846, 00643169964853, 00643169964860 |
| Serial numbers | 101, A37724-094, A37724-095, A37724-096, A37724-097, A37724-098, A37724-099, A37724-100, A37724-101, A37724-102, A37724-103, A37724-104, A37724-105, A37724-106, A37724-107, A37724-108, A37724-109, A37724-110, A37724-111, A37724-112, A37724-113, A37724-114, A37724-115, A37724-116, A37724-117 and 475 more |
| Model numbers | 41120, 41150, T41110, T41110INT, T41120, T41120INT, T41130, T41130INT, T41150, T41150INT |
Product
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; 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-1333-2023. 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.