Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen indicator (endotoxin) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling 400 units of INFUSE(R) Bone Graft, MEDIUM KIT (REF 7510400AUS). The recall is being conducted because the kits contain a collagen sponge that was previously recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
The affected lots are M111063AAF and M111064AAN. These products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, the Netherlands, New South Wales, Panama, and Paraguay.
Consumers and healthcare providers should stop using the affected products and contact Medtronic or their supplier for instructions on how to return the kits.
The recalled product
- Product
- INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Orthopaedic
- Hazard
- Affected units
- 400
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)
- Lots: M111063AAF
- M111064AAN
Distribution
Part of a larger recall action
This product is one of 7 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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