Reported Apr 12, 2023 · Ongoing
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115;…
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
S44105 | DBM S44105 GRAFTON 5CC CRUNCH |
S44115 | DBM S44115 GRAFTON 15CC CRUNCH |
T44105 | DBM T44105 5CC GRAFTON CRUNCH |
T44105INT | DBM T44105INT 5CC GRAFTON CRUNCH |
T44115 | DBM T44115 15CC GRAFTON CRUNCH |
T44115INT | DBM T44115INT 15CC GRAFTON CRUNCH, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S44105 GRAFTON 5CC CRUNCHREF S44105GTIN 00613994961099
- Serial Numbers
A41055A41991b) DBM S44115 GRAFTON 15CC CRUNCHREF S44115GTIN 00613994961082
- Serial Numbers
A46383A43751A43940A44572c) DBM T44105 5CC GRAFTON CRUNCHREF T44105GTIN 00643169123120
- Serial Numbers
1,078 of 1,078 codes
A38507-041A38507-042A38507-043A38507-044A38507-045A38507-046A38507-047A38507-048A38507-049A38507-050A40379-096A40379-097A40379-098A40379-099A40379-100A40379-101A40379-102A40379-103A40379-104A40379-105A40379-106A40379-107A40379-108A40379-109A40379-110A40379-111A40379-112A40379-113A40379-114A40379-115A40379-116A41167-031A41167-032A41167-033A41167-036A41167-037A41167-038A41167-039A41167-040A41167-041A41167-042A41167-043A41167-044A41167-045A41167-046A41167-047A41167-048A41167-049A41167-050A41167-051A41167-052A41167-053A41167-054A41167-055A41167-056A41167-057A41167-058A41167-059A41167-060A41167-061
- Serial Numbers
519 of 519 codes
A38507-051A38507-052A38507-053A38507-054A38507-055A38507-056A38507-057A38507-058A38507-059A38507-060A38507-061A38507-062A38507-063A38507-064A38507-065A38507-066A38507-067A39972-046A39972-047A39972-048A39972-049A39972-050A39972-051A39972-052A39972-053A39972-054A39972-055A39972-056A39972-057A39972-058A39972-059A39972-060A39972-061A39972-062A39972-063A39972-064A39972-065A39972-066A39972-067A39972-068A39972-069A39972-070A39972-071A39972-072A39972-073A39972-074A39972-075A39972-076A39972-077A39972-078A39972-079A39972-080A41213-031A41213-032A41213-033A41213-034A41213-035A41213-036A41213-037A41213-038
- Serial Numbers
1,086 of 1,086 codes
A26631-051A26631-052A26631-053A26631-054A26631-055A26631-056A26631-057A38377-125A38377-126A38377-127A38377-128A38377-129A38377-130A38377-131A38377-132A38377-133A38471-041A38471-042A38471-043A38471-044A38471-045A38471-046A38471-047A38472-047A38472-048A38472-049A38472-050A38472-051A38472-052A38796-048A38796-049A38796-050A38796-051A38796-052A38796-053A38796-054A38796-055A38796-056A38796-057A38796-058A38796-059A38796-060A38796-061A38796-062A38796-063A38796-064A38796-065A38796-066A38796-067A39047-108A39047-109A39047-110A39047-111A39047-112A39047-113A39091-085A39091-086A39091-087A39091-088A39091-089
- Amount recalled
- 5308 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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