Medical device recalls Moderate risk

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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