Reported Nov 1, 2023 · Ongoing
Grafton DBM (Flex), Model Numbers: T42100, 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 (Flex)
- Model NumbersT42100, Demineralized Bone Matrix
- Lot codes and dates
- GTIN 00643169123007
- Serial Numbers
77 of 77 codes
A57164-040A58820-011A57164-041A57164-042A59190-046A59190-041A59190-042A59190-043A59190-044A59190-045A57164-026A57164-027A57164-028A57164-029A57164-030A57164-031A57164-032A57164-033A58820-017A58820-018A57164-011A57164-012A57164-013A57164-014A57164-015A57164-016A57164-017A57164-018A57164-019A57164-020A57164-021A57164-022A57164-023A57164-024A57164-025A57164-034A57164-035A57164-036A57164-037A57164-038A57164-039A58820-012A58820-013A58820-014A58820-015A58820-016A58820-019A58820-020A58820-021A58820-022A58820-023A58820-024A58820-025A58820-026A58820-027A58820-028A58820-029A58820-030A58820-031A58820-033
- Amount recalled
- 77 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.
Free recall alerts
Get alerted about new Medtronic Sofamor Danek USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.