Infuse Bone Graft X Small KIT recall
INFUSE Bone Graft X SMALL KIT REF 7510100
Why was Infuse Bone Graft X Small KIT recalled?
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 00613994239525, Lot Number M111806AAA
- Product
- INFUSE Bone Graft X SMALL KIT REF 7510100
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 138 units
- Distribution
- US
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)