Reported Apr 12, 2023 · Ongoing
Medtronic Grafton Matrix Strips
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 Strips
10 of 10 products
| Model / number | Product as published |
|---|---|
S42275 | DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS |
S42280 | DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS |
T42275 | DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M |
T42275AUS | DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S |
T42275INT | DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S |
T42275JPN | DBM T42275JPN GRAFTON MATRIX 1CM X 10CM |
T42280 | DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M |
T42280AUS | DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S |
T42280INT | DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S |
T42280JPN | DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, ; Demineralized Bone Matrix (DBM) product |
- Lot codes and dates
a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPSREF S42275GTIN 00613994960931
- Serial Numbers
A42914A43126A43182A43185A43460A43613A43715A43896A44262A44388A44561A45997A46401A46690A46699A47001A47719A47942A48136A48371A48792A49045A49089A49108A49790A49952A50039A50528A50688A51827A52539A52601A52788A53401A53671A53788A53881A53904A54204A54988A55032A55132b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPSREF S42280GTIN 00613994960924
- Serial Numbers
A42850A43731A44343A44529A44821A45022A45035A46734A47604A47621A47701A47971A48051A48578A49616A51011A52580A52809A54208A54369A54440A54597A55584c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON MREF T42275GTIN 00643169123076
- Serial Numbers
2,650 of 2,650 codes
A39563-061A39563-062A39563-063A39563-064A39563-065A39563-066A39563-068A39563-070A39563-071A39563-072A39563-073A39563-074A39563-075A39563-076A39563-077A40837-011A41106-011A41106-012A41106-013A41106-014A41106-015A41106-016A41106-017A41106-018A41106-019A41558-011A41558-012A41558-013A41558-014A41558-015A41558-016A41656-011A41656-012A41656-013A41656-014A41656-015A41656-016A41656-017A41656-018A41656-019A41656-020A41656-021A41656-022A41656-023A41656-024A41656-025A41656-026A41656-027A41656-028A41656-029A41656-030A41656-031A41656-032A41656-033A41656-034A41656-035A41656-036A41656-037A41656-038A41656-039
- Amount recalled
- 23850 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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