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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Intervertebral body Fixation Orthosis

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  Class 2 Device Recall Spinal Intervertebral body Fixation Orthosis see related information
Date Initiated by Firm March 22, 2012
Date Posted May 14, 2012
Recall Status1 Terminated 3 on November 18, 2013
Recall Number Z-1545-2012
Recall Event ID 61804
510(K)Number K073708  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***".

Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Code Information Serial Number: 002, 004, 007, 009, 011, 015, 017, 018, 019, 020, 024, 025, 035 and 030.
Recalling Firm/
Manufacturer		 Captiva Spine, Inc
967 Alternate A1A
Suite1
Jupiter FL 33477
For Additional Information Contact Tamala J. Wampler
561-277-9480
Manufacturer Reason
for Recall		 Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Captiva Spine sent a "VOLUNTARY CORRECTION NOTIFICATION" letter dated March 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides steps for the correction and a verification form for customers to complete. Customers should contact the firm at 877-772-5571 for questions concerning this notice.
Quantity in Commerce 14 units
Distribution Nationwide Distribution including the states of FL, IN, UT, GA, PA, TX, AL, NC, 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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