Device product
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Z-2107-2013
Product summary
- Firm
- SpineNet
- Event
- Event 65914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-2107-2013
Official wording
Reason: SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Code information: Lot # 22754F16 and #25854I17
Distribution pattern: Distributed to one customer in Florida.
Derived failure modes
-
Unknown
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.