Z-2107-2013 Class II Terminated
FDA device recall Z-2107-2013 was initiated by SpineNet on February 4, 2013 and is designated Class II. Reason for recall: SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval. The recall status is terminated (terminated November 15, 2013). Affected quantity: 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- February 4, 2013
- Termination Date
- November 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
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.
Distribution Pattern
Distributed to one customer in Florida.
Code Information
Lot # 22754F16 and #25854I17