Medtronic Recalls Grafton DBM Products Due to Donor Microbial Presence
Medtronic is recalling specific Grafton DBM and Grafton Plus DBM products because the donor tissue tested positive for Clostridium butyricum, posing a potential infection risk.
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
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source identifies a potential for Clostridium butyricum infection if the product is implanted. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 20 units of Grafton DBM and Grafton Plus DBM products. These medical devices are demineralized human bone tissue allografts used for implantation. The recall involves specific serial numbers ranging from A62881-014 through A62881-033, identified by UDI-DI 00643169122932.
The recall was initiated after a donor record review revealed that the donor for batch A62881 did not meet all eligibility requirements regarding the presence of microbial organisms. Specifically, the donor bone tissue tested positive for Clostridium butyricum. Although the tissue underwent gamma radiation and the finished product passed sterility testing, Medtronic is retrieving any unused product to prevent potential clostridium infection if the product were implanted.
The affected products were distributed nationwide in the states of Oklahoma, Virginia, Colorado, Arkansas, Florida, Texas, Maryland, Delaware, Illinois, Michigan, Kansas, Alabama, and Georgia. Healthcare providers and facilities should check their inventory for the specific serial numbers listed and stop using any unused units. Patients who have already received these implants should contact their healthcare provider for guidance.
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 — Bone Graft
- Affected units
- 20
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 (20)
- UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033
- specifically: A62881-014
- A62881-015
- A62881-016
- A62881-017
- A62881-018
- A62881-019
- A62881-020
- A62881-021
- A62881-022
- A62881-023
- A62881-024
- A62881-025
- A62881-026
- A62881-027
- A62881-028
- A62881-029
- A62881-030
- A62881-031
- A62881-032
Distribution
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