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.
What this means for you
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 criteria for a risk-of-harm product without reported injury.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400. The recall involves 8,884 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 was initiated 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 M111063AAA, M111063AAB, M111064AAI, M111064AAF, M111064AAE, 111064AAT, M111064AAU, M111064AAX, M111064AAJ, M111064AAR, and M111064AAS.
Healthcare providers and patients should stop using the affected kits and contact Medtronic Sofamor Danek USA Inc for further instructions.
The recalled product
- Product
- INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, 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
- 8,884
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 (11)
- Lots: M111063AAA
- M111063AAB
- M111064AAI
- M111064AAF
- M111064AAE
- 111064AAT
- M111064AAU
- M111064AAX
- M111064AAJ
- M111064AAR
- M111064AAS
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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