FDA Device recall Z-0440-2019
INFUSE Bone Graft X SMALL KIT REF 7510100
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of INFUSE Bone Graft X SMALL KIT REF 7510100 by Medtronic Sofamor Danek Usa, citing the Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0440-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-27 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
Product
INFUSE Bone Graft X SMALL KIT REF 7510100
Reason
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Identifiers
| code_info | UDI 00613994239525, Lot Number M111806AAA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0440-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.