Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling 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 medical device with a risk of harm (elevated endotoxin) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Sofamor Danek USA, Inc. is recalling INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800. The recall involves 16,994 units distributed worldwide, including the United States (nationwide including Puerto Rico) and internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, New South Wales, Panama, and Paraguay.
The recall is due to the kits containing a collagen sponge that was recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. The affected lots are M111103AAG, M111052AAQ, M111052AAR, M111052AAP, M111052AAL, M111059AAC, M111059AAF, M111052AAF, M111059AAH, M111103AAB, M111059AAG, M111052AAK, M111052AAJ, M111059AAB, M111059AAK, M111052AAI, M111052AAO, M111052AAH, M111052AAG, and M111059AAD.
Healthcare providers and patients should stop using the affected kits and contact Medtronic for further instructions.
The recalled product
- Product
- INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, 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
- 16,994
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)
- Lots: M111103AAG
- M111052AAQ
- M111052AAR
- M111052AAP
- M111052AAL
- M111059AAC
- M111059AAF
- M111052AAF
- M111059AAH
- M111103AAB
- M111059AAG
- M111052AAK
- M111052AAJ
- M111059AAB
- M111059AAK
- M111052AAI
- M111052AAO
- M111052AAH
- M111052AAG
- M111059AAD
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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