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U.S. Department of Health and Human Services

Class 2 Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System.

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  Class 2 Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System. see related information
Date Initiated by Firm November 22, 2011
Date Posted May 23, 2012
Recall Status1 Terminated 3 on November 18, 2013
Recall Number Z-1649-2012
Recall Event ID 61811
510(K)Number K073708  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product 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.

Code Information Lot Numbers: 1500705A, 06110041, 1500707A, 06110043, 1500708A, and 06110044
Recalling Firm/
Manufacturer		 Captiva Spine, Inc
967 Alternate A1A
Suite1
Jupiter FL 33477
For Additional Information Contact Tamala Wampler
561-277-9480
Manufacturer 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
FDA Determined
Cause 2		 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 105 units
Distribution Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = PRECISION SURGERY LTD.
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