Device product

INFUSE Bone Graft X SMALL KIT REF 7510100

Z-0440-2019

September 27, 2018

Class II

Product summary

Firm: Medtronic Sofamor Danek USA Inc
Event: Event 81171
Status: Terminated
Classification: Class II
Quantity: 138 units
Official record key: device-enforcement:Z-0440-2019

Official wording

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

Code information: UDI 00613994239525, Lot Number M111806AAA

Distribution pattern: US

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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