INFUSE Bone Graft recallZ-0440-2019 · Medtronic Sofamor Danek USA Inc · initiated Sep 27, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
FDA root cause category: Error in labeling
What the company is doing
The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
Recall details
- Recall number
- Z-0440-2019
- Status
- Terminated
- Initiated by the company
- Sep 27, 2018
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 138 units
- Product code
- NEK
- FDA submissions
- P000058, P050053
- Distribution
- US
Product description
INFUSE Bone Graft X SMALL KIT REF 7510100
Code information (models, lots, serial numbers)
UDI 00613994239525, Lot Number M111806AAA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INFUSE® Bone Graft 7510100Medtronic Sofamor Danek, Inc. · Bone grafting material, dental, with biologic component1 recall23 reports
Product lines
Other devices under the same FDA submission
29 devices cleared under P000058, P050053 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- INFUSE® Bone Graft 7510800Medtronic Sofamor Danek, Inc. · Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction180 reports
- INFUSE® Bone Graft 7510200Medtronic Sofamor Danek, Inc. · FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION143 reports
- INFUSE® Bone Graft 7510400Medtronic Sofamor Danek, Inc. · FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION132 reports
- INFUSE® Bone Graft 7510600Medtronic Sofamor Danek, Inc. · Bone grafting material, dental, with biologic component69 reports
- INFUSE® Bone Graft 7510050Medtronic Sofamor Danek, Inc. · Bone grafting material, dental, with biologic component29 reports
- Clydesdale™ Spinal System 2968250Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar10 reports
- Clydesdale™ Spinal System 2968050Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar7 reports
- Clydesdale™ Spinal System 2968255Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar6 reports
- Clydesdale™ Spinal System 2968045Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar5 reports
- Clydesdale™ Spinal System 2968245Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar4 reports
- Clydesdale™ Spinal System 2922255Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar3 reports
- Clydesdale™ Spinal System 2922055Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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