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 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling 2,090 units of INFUSE(R) Bone Graft, LARGE II KIT (REF 7510800AUS). 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 M111103AAC, M111052AAT, M111059AAE, M111054AAR, and M111052AAM. The product was 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.
The source text does not specify specific actions for consumers or patients. The recall is classified as Class II by the FDA.
The recalled product
- Product
- INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, 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
- 2,090
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: M111103AAC
- M111052AAT
- M111059AAE
- M111054AAR
- M111052AAM
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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