RegWardenFDA facility compliance records
Company

SpineNet

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 2 recalls2’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-02-05
    The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
  • Class IITerminated2013-02-04
    SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SpineNet — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10022679-spinenet/

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