Recall Z-0440-2019— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2018-09-27, terminated 2020-09-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-27
- Terminated
- 2020-09-16
- Firm location
- Memphis, TN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.