Z-0440-2019 Class II Terminated

Recalled by Medtronic Sofamor Danek USA Inc — Memphis, TN

Recall Details

Product Type
Devices
Report Date
November 21, 2018
Initiation Date
September 27, 2018
Termination Date
September 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
138 units

Product Description

INFUSE Bone Graft X SMALL KIT REF 7510100

Reason for Recall

The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

Distribution Pattern

US

Code Information

UDI 00613994239525, Lot Number M111806AAA