RegWardenFDA facility compliance records
Recall

Class II — SpineNet

Recalling firmSpineNet
Registered facilitySpineNet LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
ProductSpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Quantity100 units
DistributionDistributed to one customer in Florida.
Initiated2013-02-04
Classified2013-08-27
Terminated2013-11-15
Recall numberZ-2107-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — SpineNet (Z-2107-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65914/

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