Medtronic Sofamor Danek USA Inc recalls INFUSE Bone Graft X SMALL KIT REF 7510100
- Recall date
- September 27, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0440-2019
- FDA classification
- Class II
- Brand / firm
- Medtronic Sofamor Danek USA Inc
- Sold / distributed
- US
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
INFUSE Bone Graft X SMALL KIT REF 7510100
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