Recall Z-2107-2013— SpineNet
Class II · Terminated
Class II FDA medical device recall by SpineNet, initiated 2013-02-04, terminated 2013-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.. Reason: SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval..
- Recalling firm
- SpineNet
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-04
- Terminated
- 2013-11-15
- Firm location
- Winter Park, FL, United States
Product description
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Reason for recall
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.