CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
Bone Marrow Aspiration Needle Kit recalled by SpineNet
SpineNet is recalling SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration, distributed in Florida. The recall was initiated on 4 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2107-2013
- FDA event ID
- 65914
- Recalling firm
- SpineNet, Winter Park, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2013
- FDA classified
- 27 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 4 Feb 2013 | Recall initiated by company | |
| 27 Aug 2013 | Classified by FDA | +204 days |
| 4 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Product as listed by the FDA
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Where it was distributed
Distributed to one customer in Florida.
Questions about this recall
Is Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle recalled?
Yes. SpineNet recalled Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle on 4 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-2107-2013.
Why was it recalled?
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Which lots are affected?
Lot # 22754F16 and #25854I17
Where was it sold?
Distributed to one customer in Florida.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SpineNet
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|---|---|---|---|---|---|
| Device | CLASS II | Anterior Cervical Cage, Lordotic, Peek recalled by SpineNet | SpineNet | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |