RegWardenFDA facility compliance records
Recall

Class II — Captiva Spine, Inc

Recalling firmCAPTIVA SPINE
Registered facilityCAPTIVA SPINE, Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonIt is possible for the titanium color-coded ring to detach from the Reamers.
ProductCaptiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Quantity233 devices
DistributionGA, IN, FL, UT, AZ, CA, and NY
Initiated2015-02-25
Classified2015-04-21
Terminated2015-06-01
Recall numberZ-1480-2015
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 — Captiva Spine, Inc (Z-1480-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70710/

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