Reported Nov 1, 2023 · Ongoing
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; 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 DBM Matrix Strips
- Model Numbers
a) T42275b) T42280Demineralized Bone Matrix
- Lot codes and dates
- a) T42275GTIN 00643169123076
- Serial Numbers
214 of 214 codes
A58988-042A58156-043A59160-040A59343-027A58156-049A58988-029A58821-051A58156-050A59343-029A59343-030A59343-031A59343-032A59343-033A59269-016A59154-026A59343-043A59160-046A59154-038A59154-039A59154-040A59154-041A59154-042A58821-048A58821-049A59343-020A59343-021A59343-024A59343-025A59343-026A58821-056A58821-057A58988-040A59154-031A59160-044A58988-018A58821-026A58821-027A58821-028A58821-029A58821-030A58988-019A58988-020A58988-021A59119-027A58156-042A58821-053A58821-054A58821-055A58988-043A58988-044A58988-045A59119-011A59119-012A59119-013A59119-014A59119-015A59119-016A59119-017A59119-032A59119-033
- Serial Numbers
70 of 70 codes
A58840-084A58489-021A57660-021A58489-023A58489-024A58812-035A58812-038A58582-011A58264-023A58264-024A58264-025A58264-011A58264-012A58489-017A58489-018A58840-087A58489-011A58085-011A58840-091A58812-031A58840-088A58840-086A58812-041A58812-042A58812-032A58812-033A58812-034A58840-080A57660-011A57660-012A57660-013A57660-014A57660-017A57660-018A58264-013A58812-045A58840-076A58840-077A58840-078A57660-019A57660-020A58840-082A58489-022A57660-015A57660-016A58812-039A58840-079A58840-085A58264-014A58489-020A58812-037A58812-043A58812-044A58840-081A58840-083A58812-040A58489-019A58812-036A58840-089A58264-015
- Amount recalled
- 282 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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