Reported Apr 12, 2023 · Ongoing
Medtronic Grafton Orthoblend
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?
Medtronic Grafton Orthoblend
15 of 15 products
| Model / number | Product as published |
|---|---|
S44125 | DBM S44125 5CC ORTHOBLEND LARGE DEFECT |
S44135 | DBM S44135 15CC ORTHOBLEND LARGE DEFECT |
S44145 | DBM S44145 5CC ORTHOBLEND SMALL DEFECT |
S44150 | DBM S44150 10CC ORTHOBLEND SMALL DEFECT |
T44125 | DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT |
T44125AUS | DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG |
T44125INT | DBM T44125INT 5CC GRAFTON ORTHOBLEND LG |
T44135 | DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF |
T44135INT | DBM T44135INT 15CC GRAFTON ORTHOBLEND LG |
T44145 | DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT |
T44145AUS | DBM T44145AUS 5CC GRAFTON ORTHOBLEND SM |
T44145INT | DBM T44145INT 5CC GRAFTON ORTHOBLEND SM |
T44150 | DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF |
T44150AUS | DBM T44150AUS 10CC GRAFTON ORTHOBLEND SM |
T44150INT | DBM T44150INT 10CC GRAFTON ORTHOBLEND SM, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S44125 5CC ORTHOBLEND LARGE DEFECTREF S44125GTIN 00613994961075
- Serial Numbers
A47433A48675b) DBM S44135 15CC ORTHOBLEND LARGE DEFECTREF S44135GTIN 00613994961068
- Serial Numbers
A42664c) DBM S44145 5CC ORTHOBLEND SMALL DEFECTREF S44145GTIN 00613994961051
- Serial Numbers
A40910A48944A52283d) DBM S44150 10CC ORTHOBLEND SMALL DEFECTREF S44150GTIN 00613994961044
- Serial Numbers
A43743e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFTREF T44125GTIN 00643169122901
- Serial Numbers
434 of 434 codes
A41627-069A41627-070A41627-071A41627-072A41627-073A41627-074A41627-076A41627-077A41627-078A41627-079A41627-080A41627-081A41627-083A41627-085A41627-087A41627-088A41627-089A41627-092A41627-093A41627-094A41627-095A41755-053A41755-054A41755-055A41755-056A41755-057A41755-058A41755-059A41755-060A41755-061A41755-062A41755-063A41755-064A41755-065A41755-066A41755-067A41755-068A41755-071A41755-072A41755-073A41755-074A41755-076A41755-077A41755-078A41755-079A41755-082A41755-083A41755-084A41755-085A41755-086A41755-087A41755-088A41755-089A41755-090A41755-091A41755-092A41755-093A41755-094A41755-095A41755-096
- Serial Numbers
A42115-061A42115-062A42115-063A44487-057A44487-058A44487-059A44487-060A44487-061A44487-062A44487-063A44487-064A44487-065A44487-066A44487-067A44487-068A46117-055A46117-056A46117-057A46117-058A46117-059A47598-134A47598-135A47598-136A47598-138A47598-139A47598-140A47598-141A47598-142A47598-143A49862-054A49862-055g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LGREF T44125INTGTIN 00643169965058
- Serial Numbers
2,194 of 2,194 codes
A38959-090A38959-091A38959-092A38959-093A38959-094A38959-095A38959-096A38959-097A38959-098A38959-099A38959-100A38959-101A38959-102A38959-103A38959-104A38959-105A38959-106A38959-107A38959-108A38959-109A38959-110A38959-111A38959-112A40657-034A40657-035A40657-036A40657-037A40657-038A40657-039A40657-040A40657-041A40657-042A40657-043A40657-044A40657-045A40657-046A40657-047A40657-048A40657-049A40657-050A40657-051A40657-052A40657-053A40657-054A40657-055A40657-056A40657-057A40657-058A40657-059A40657-060A40657-061A40657-062A40657-063A40657-064A40657-065A40657-066A40657-067A40657-068A40657-069A40657-070
- Amount recalled
- 30541 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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