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U.S. Department of Health and Human Services

Class 2 Device Recall Picasso II MIS Spinal System CTL Medical Hex Driver

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  Class 2 Device Recall Picasso II MIS Spinal System CTL Medical Hex Driver see related information
Date Initiated by Firm July 05, 2018
Date Posted March 20, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-1031-2019
Recall Event ID 82201
510(K)Number K132365  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Code Information Lot 7EQBB-C
Recalling Firm/
Manufacturer		 CTL Medical Corporation
4550 Excel Pkwy Ste 300
Addison TX 75001-5714
For Additional Information Contact Sergiu Vrabie
214-545-5833
Manufacturer Reason
for Recall		 the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The anti-toggle ring of the HEX Driver, 1/4", square QC, 40 can separate form the driver shaft.
Quantity in Commerce 133 total devices
Distribution distributor and user level
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 = NKB and Original Applicant = ACCEL SPINE
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