Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
FDA Recall Z-1648-2012 · Posted 2012-05-23
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Recalling FirmCaptiva Spine, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2011-11-22
Date Terminated2013-11-18
Product Quantity212 units
Reason for Recall
Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime
Firm Action
Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels.
For questions customers should call 877-772-5571.
For questions regarding this recall call 561-277-9480.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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