FDA Device recall Z-1333-2023
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120 by Medtronic Sofamor Danek Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1333-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-08 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC…a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1333-2023%22
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