Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert a
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection
The recalled product
- Product
- Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Devices
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051
- specifically: A62881-034
- A62881-035
- A62881-036
- A62881-037
- A62881-038
- A62881-039
- A62881-040
- A62881-041
- A62881-042
- A62881-043
- A62881-044
- A62881-045
- A62881-046
- A62881-047
- A62881-048
- A62881-049
- A62881-050
- A62881-051
Distribution
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