Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2018 - (Recall #: Z-0440-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

INFUSE Bone Graft X SMALL KIT REF 7510100

Product Classification:

Class II

Date Initiated: September 27, 2018

Date Posted: November 21, 2018

Recall Number: Z-0440-2019

Event ID: 81171

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.

Status: Terminated

Product Quantity: 138 units

Code Information:

UDI 00613994239525, Lot Number M111806AAA

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated