Reported Nov 1, 2023 · Ongoing
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; 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 Orthoblend
- Model Numbers
a) T44125INTb) T44135c) T44145d) T44150Demineralized Bone Matrix
- Lot codes and dates
- a) T44125INTGTIN 00643169965058
- Serial Numbers
A52559-042A52559-024A52559-038A52559-039A52559-040A52559-041A52559-044A52559-045A52559-021A52559-022A52559-023A52559-025A52559-026A52559-027A52559-028A52559-029A52559-030A52559-031A52559-032A52559-033A52559-034A52559-035A52559-036A52559-037A52559-043
- b) T44135GTIN 00643169122918
- Serial Numbers
108 of 108 codes
A59102-034A59102-035A58789-025A58789-026A58789-027A59080-036A59080-037A58789-030A58789-031A58789-032A58789-033A58789-034A58789-035A58789-036A58789-037A58789-038A58789-039A59102-042A59102-043A59102-044A59102-045A59102-046A59102-047A59102-048A59102-049A59102-050A59102-051A59103-030A59103-031A59103-032A59103-033A59103-034A59103-035A59103-036A59103-037A59103-038A59103-039A59102-055A59102-056A58789-061A58789-062A59080-022A59080-026A59080-027A59080-028A59080-029A59080-030A59102-038A59102-039A59102-040A59102-041A59102-059A59102-060A59102-061A59102-062A58789-047A59103-042A59103-043A59103-044A59103-045
- c) T44145GTIN 00643169122925
- Serial Numbers
172 of 172 codes
A56911-076A56911-070A56911-071A56911-023A56911-067A47028-065A56911-082A59197-041A59197-059A56911-074A56911-075A47028-053A57248-034A56911-018A59197-057A59197-036A59197-037A59197-020A59197-021A59197-022A59197-023A59197-024A56911-028A56911-029A56911-030A56911-031A56911-033A57248-039A56911-034A56911-035A56911-080A59197-034A56911-077A56911-078A56911-079A59197-047A59197-044A56911-068A56911-044A56911-045A56911-046A56911-081A57248-020A57248-032A57248-036A59197-062A56911-032A59197-055A59197-051A59197-052A57248-025A57248-026A57248-027A57248-028A57248-029A56911-041A59197-048A56911-020A56911-024A56911-025
- d) T44150GTIN 00643169122932
- Serial Numbers
125 of 125 codes
A48245-164A48245-168A57914-011A57914-012A57914-023A57914-024A57914-025A59191-061A59191-058A58758-035A58758-036A58758-037A58758-059A59191-038A59191-039A58758-034A58758-038A59191-040A48245-121A48245-122A48245-123A48245-124A48245-147A48245-148A48245-149A48245-160A48245-170A58758-060A58758-061A58758-062A59191-062A59191-063A59191-064A58758-039A57914-013A57914-014A57914-015A57914-016A57914-017A58758-040A58758-041A58758-042A59191-041A58758-043A58758-044A48245-165A48245-166A48245-167A48245-169A58758-045A58758-046A58758-050A58758-051A58758-047A58758-048A58758-049A59191-042A59191-043A59191-044A58758-031
- Amount recalled
- 430 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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