Reported Nov 1, 2023 · Ongoing
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone 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?
- Grafton DMB Matrix
- Model Numbers
a) T42200b) T42210Demineralized Bone Matrix
- Lot codes and dates
- a) T42200GTIN 00643169123052
- Serial Numbers
214 of 214 codes
A59254-013A57871-018A59117-013A59254-018A59264-016A58526-014A58526-015A58526-016A58864-018A58082-016A58983-011A58983-012A59320-013A59320-016A57043-011A58831-018A59307-012A59320-019A58831-019A59117-020A57104-018A58408-015A58408-016A58952-019A59307-011A59264-014A58526-011A58526-012A58408-011A58995-025A59140-014A59140-015A59165-012A56808-011A56808-012A57078-011A57078-012A58077-013A59117-021A59264-015A57871-014A56808-019A56808-020A57078-013A57078-014A57078-015A57078-016A57078-017A58649-011A58649-012A58649-013A58649-014A58649-015A58649-016A58649-017A58983-018A58983-019A58983-020A59117-011A59117-015
- b) T42210GTIN 00643169123069
- Serial Numbers
163 of 163 codes
A58133-043A59122-023A58133-046A58518-019A58518-020A57362-017A57362-019A58545-022A58133-045A57362-011A58545-028A59122-022A57344-020A59122-017A57344-021A58133-044A59122-018A57344-022A57344-018A57344-019A58545-024A58518-015A58545-011A58545-012A58133-047A58518-011A58518-012A58518-013A58518-014A58122-011A58122-012A58122-013A58122-014A58122-015A58122-016A58122-017A58122-018A57344-023A58518-016A57387-026A57387-027A58518-017A58518-018A58545-013A58545-014A57387-029A58518-031A57344-024A57387-011A57387-012A57387-013A57387-014A57387-015A59122-019A59122-020A59122-021A59122-024A58518-021A58518-022A58518-023
- Amount recalled
- 377 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
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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