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Terminated

Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. 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-1649-2012 · Posted 2012-05-23

Recalling FirmCaptiva Spine, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2011-11-22
Date Terminated2013-11-18
Product Quantity105 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.

K073708FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEMPrecision Surgery , Ltd. · 2008-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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