Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns
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 potential contamination hazard (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 KIT, REF 7510600. The recall involves 4,885 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 being conducted because the kits contain a collagen sponge that was recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. The affected lots are M111052AAE, M111052AAN, M111052AAS, M111052AAD, and M111059AAA.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is in use, contact Medtronic or the FDA for further instructions on how to proceed.
The recalled product
- Product
- INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, 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
- 4,885
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 (5)
- Lots: M111052AAE
- M111052AAN
- M111052AAS
- M111052AAD
- M111059AAA
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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