Reported Apr 12, 2023 · Ongoing
Medtronic Grafton Matrix
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 Matrix
10 of 10 products
| Model / number | Product as published |
|---|---|
S42200 | DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX |
S42210 | DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX |
T42200 | DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT |
T42200AUS | DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX |
T42200INT | DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M |
T42200JPN | DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM |
T42210 | DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR |
T42210AUS | DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX |
T42210INT | DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M |
T42210JPN | DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIXREF S42200GTIN 00613994960955
- Serial Numbers
A40821A41333A42693A42811A43336A43592A44884A44960b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIXREF S42210GTIN 00613994960948
- Serial Numbers
A42415A42482A42953A43212A43354A43965A44760A45028A46673A48105A48484A49062A49564A50856A52420A52719A52904A53373c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MATREF T42200GTIN 00643169123052
- Serial Numbers
2,676 of 2,676 codes
A38910-046A38910-047A38910-048A38910-049A38910-050A38910-051A38910-052A38910-053A38910-054A38910-055A38910-056A38910-057A39374-061A39374-062A39374-063A39374-064A39374-065A39374-066A39374-067A39374-068A39374-069A39374-070A39374-071A39374-072A39736-021A39736-022A39736-023A39736-024A39736-025A39736-026A39736-027A39736-028A39736-029A39736-030A39736-031A39736-032A39803-051A39803-052A39803-053A39803-054A39803-055A39803-056A39803-057A39803-058A39803-059A39803-060A39803-061A39803-062A40169-050A40169-051A40169-052A40169-053A40169-054A40169-055A40169-056A40169-057A40327-056A40327-057A40327-058A40327-059
- Amount recalled
- 19057 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.
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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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