Z-0440-2019Class II

INFUSE Bone Graft X SMALL KIT REF 7510100

Name: Z-0440-2019 INFUSE Bone Graft X SMALL KIT REF 7510100
Creator: Medtronic Sofamor Danek USA Inc
Published: 2018-09-27
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2018-09-27 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek USA Inc began a recall of INFUSE Bone Graft X SMALL KIT REF 7510100 on 2018-09-27. FDA classified it as Class II and gives the reason as "The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0440-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-27
Posted: 2018-11-09
Terminated: 2020-09-16
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: INFUSE Bone Graft X SMALL KIT REF 7510100
Product code: NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
Quantity in commerce: 138 units
Distribution: US
Product codes and lots: UDI 00613994239525, Lot Number M111806AAA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0440-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0440-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code NEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)