Medtronic Recalls INFUSE Bone Graft Kits Due to Extra Sponges
Medtronic is recalling 138 units of INFUSE Bone Graft X Small Kits because they may contain two absorbable collagen sponges instead of one.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity recall involving a product defect without reported harm.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 138 units of the INFUSE Bone Graft X Small Kit (REF 7510100). The affected units are from Lot Number M111806AAA and have UDI 00613994239525.
The recall was initiated because the kits may contain two absorbable collagen sponges (ACS) when they should only contain one. The source text does not specify the distribution locations beyond the United States or provide details on reported injuries or illnesses.
Healthcare providers and patients should check their inventory for this specific lot number and contact Medtronic for further instructions on how to handle the affected kits.
The recalled product
- Product
- INFUSE Bone Graft X SMALL KIT REF 7510100
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Bone Graft
- Affected units
- 138
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 (2)
- UDI 00613994239525
- Lot Number M111806AAA
Distribution
Distribution scope not specified by the agency.
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