Reported Nov 1, 2023 · Ongoing
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; 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 Plus DBM Paste
- Model Numbers
a) T45001b) T45005c) T45010Demineralized Bone Matrix
- Lot codes and dates
- a) T45001GTIN 00643169122949
- Serial Numbers
375 of 375 codes
A48245-111A58751-114A57260-060A57260-063A58751-112A58751-113A57260-083A57260-084A58428-149A58428-150A57260-082A58428-148A58751-111A57260-078A58428-141A48245-075A48245-076A57260-075A58751-096A57260-079A58428-147A58428-128A57260-072A57260-059A57260-067A57260-068A57260-069A48245-105A48245-106A57256-160A58751-100A57256-161A48245-113A57256-164A58799-167A58799-168A58799-169A58799-170A58799-171A57256-170A48245-107A48245-108A57256-136A58751-108A48245-079A48245-082A48245-083A48245-084A48245-086A58751-070A58751-071A58751-072A58751-073A58751-074A58751-075A58751-076A58751-115A58799-087A48245-101A58799-165
- b) T45005GTIN 00643169123021
- Serial Numbers
141 of 141 codes
A58746-016A57923-013A59083-037A57923-022A57878-072A58720-014A58720-015A57261-045A57261-046A57261-047A59083-048A58973-023A58973-024A58973-025A58973-026A58973-027A59132-021A59132-022A59132-023A59132-024A59132-025A59132-026A59132-027A59132-028A59132-029A59132-030A57878-063A57878-064A57878-065A57878-066A57878-067A58973-029A58973-033A58746-013A58746-015A58746-014A57923-021A59083-049A57923-011A57923-012A58746-018A58746-019A58746-020A58746-021A58746-024A57878-068A57878-069A58973-028A58746-023A58746-025A58746-029A58746-030A58746-031A58746-032A57878-070A57878-071A58746-026A58746-027A57923-014A57923-015
- c) T45010GTIN 00643169123038
- Serial Numbers
67 of 67 codes
A59231-018A59231-019A56269-064A59231-014A56269-066A59010-019A59010-021A59010-022A59010-023A56269-071A56269-072A59356-017A59356-018A59131-019A59131-020A59191-026A59231-020A59231-015A59231-016A59231-017A59010-024A59010-025A56269-065A59131-011A59131-012A59131-013A59356-011A59356-012A59356-013A59231-013A56269-061A56269-062A56269-063A59010-026A59010-027A59131-014A59131-015A59131-016A59131-017A59131-018A59191-027A59191-028A59191-029A59191-030A59191-031A59191-032A59191-033A59010-020A56269-067A56269-068A59191-034A59191-035A59191-036A59356-020A59191-037A59231-011A59356-019A56269-069A56269-070A59010-016
- Amount recalled
- 583 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.