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 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateMedtronic Recalls INFUSE Bone Graft Kits Due to Extra Sponges
FDA (Devices) · 2018-11-21
- HighMedtronic Bone Graft Recalled Due to Incorrect Size Labeling
FDA (Devices) · 2023-09-20
- HighMedtronic Grafton DBF Inject bone matrix products recalled for packaging defects
FDA (Devices) · 2023-04-12
- HighDural Graft Implants Recalled for Out-of-Specification Endotoxin Levels
FDA (Devices) · 2024-11-06
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighMedtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29