Reported Nov 1, 2023 · Ongoing
Grafton DBM Crunch, Model Numbers: T44115, 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 Crunch
- Model NumbersT44115, Demineralized Bone Matrix
- Lot codes and dates
- GTIN 00643169123113
- Serial Numbers
84 of 84 codes
A59083-054A59083-055A59083-056A59083-057A59083-058A59083-059A59083-060A59083-061A59083-062A59083-063A59083-064A56737-049A56737-050A56737-051A56737-052A56737-053A56737-054A56737-055A56737-056A56737-057A56737-058A56737-059A56737-060A56737-061A56737-062A56737-063A56858-021A56858-022A56858-023A56858-024A56858-025A56858-026A56858-027A56858-028A56858-029A56858-030A56858-031A56858-032A56858-033A56858-034A56858-035A56858-036A57174-060A57174-061A57174-062A57174-063A57174-064A57174-065A57174-066A57174-067A57174-068A57174-069A57174-070A57174-071A57617-066A57617-067A57617-068A57617-069A57617-070A57617-071
- Amount recalled
- 84 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.
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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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