Z-1648-2012

Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part...

Name: Z-1648-2012 Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part...
Creator: Captiva Spine, Inc
Published: 2011-11-22
License: https://open.fda.gov/license/

CAPTIVA SPINE, Inc. / initiated 2011-11-22 / Terminated / root cause: manufacturing process

FDA source

Captiva Spine, Inc began a recall of Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2... on 2011-11-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1648-2012
Status: Terminated
Initiated: 2011-11-22
Posted: 2012-05-23
Terminated: 2013-11-18
Recalling firm: CAPTIVA SPINE, Inc.
Product: 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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 212 units
Distribution: Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
Product codes and lots: Lot Numbers: 89427-2 R & 89427-3-R

Product code KWQ

K073708Class IIFixed, Variable & Corpectomy Cervical Plate SystemPrecision Surgery , Ltd. / cleared 2008-06-03

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)