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 injuries have been reported, 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, SMALL KIT (REF 7510200AUS). The recall involves 1,319 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 affected lots are M111063AAK, M111064AAH, M111063AAE, and M111063AAO.
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 source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients should stop using the affected kits and contact Medtronic or their local distributor for instructions on return or replacement.
The recalled product
- Product
- INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, 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
- 1,319
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 (4)
- Lots: M111063AAK
- M111064AAH
- M111063AAE
- M111063AAO
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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