FDA Device recall Z-1324-2023
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105 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-1324-2023 |
| 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 Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; 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 S44105 GRAFTON 5CC CRUNCH, REF S44105, GTIN 00613994961099, Serial Numbers: A41055, A41991; b) DBM S44115 GRA…a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105, GTIN 00613994961099, Serial Numbers: A41055, A41991; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115, GTIN 00613994961082, Serial Numbers: A46383, A43751, A43940, A44572; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105, GTIN 00643169123120, Serial Numbers: A38507-041, A38507-042, A38507-043, A38507-044, A38507-045, A38507-046, A38507-047, A38507-048, A38507-049, A38507-050, A40379-096, A40379-097, A40379-098, A40379-099, A40379-100, A40379-101, A40379-102, A40379-103, A40379-104, A40379-105, A40379-106, A40379-107, A40379-108, A40379-109, A40379-110, A40379-111, A40379-112, A40379-113, A40379-114, A40379-115, A40379-116, A41167-031, A41167-032, A41167-033, A41167-036, A41167-037, A41167-038, A41167-039, A41167-040, A41167-041, A41167-042, A41167-043, A41167-044, A41167-045, A41167-046, A41167-047, A41167-048, A41167-049, A41167-050, A41167-051, A41167-052, A41167-053, A41167-054, A41167-055, A41167-056, A41167-057, A41167-058, A41167-059, |
|---|
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-1324-2023%22
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