FDA recall Z-0440-2019
Medtronic Sofamor Danek USA Inc · Class II · device
Product
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
US
Key facts
- Status
- Terminated
- Initiation date
- 2018-09-27
- Report date
- 2018-11-21
- Termination date
- 2020-09-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2019