Z-2107-2013Class II

SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M)...

Name: Z-2107-2013 SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M)...
Creator: SpineNet
Published: 2013-02-04
License: https://open.fda.gov/license/

SpineNet LLC / initiated 2013-02-04 / Terminated

FDA source

SpineNet began a recall of SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow on 2013-02-04. FDA classified it as Class II and gives the reason as "SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2107-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Posted: 2013-08-27
Terminated: 2013-11-15
Recalling firm: SpineNet LLC
Product: SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
FDA root cause: No Marketing Application
Action: SpineNET sent a "VOLUNTARY PRODUCT RECALL" letter dated 02/04/2013 to Halifax Medical Center. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 407-539-2483 for questions regarding this notice.
Quantity in commerce: 100 units
Distribution: Distributed to one customer in Florida.
Product codes and lots: Lot # 22754F16 and #25854I17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2107-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code GAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)