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U.S. Department of Health and Human Services

Class 2 Device Recall MectaLIF Oblique Handle

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  Class 2 Device Recall MectaLIF Oblique Handle see related information
Date Initiated by Firm October 21, 2014
Date Posted November 18, 2014
Recall Status1 Terminated 3 on March 14, 2016
Recall Number Z-0225-2015
Recall Event ID 69693
510(K)Number K110927  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Code Information Model Number: 03.22.10.0262;  Lot Number: 1314256
Recalling Firm/
Manufacturer		 Medacta Usa
1556 W Carroll Ave
Chicago IL 60607-1012
For Additional Information Contact Mr. Adam Gross
805-910-6511
Manufacturer Reason
for Recall		 The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
FDA Determined
Cause 2		 Employee error
Action Medacta sent an URGENT MEDICAL DEVICE RECALL letter dated October 21, 2014 were via e-mail to all sales representatives and distributors. The letters included instructions for the sales represetantives and distributors to: 1) check their inventory for the recalled devices; 2) immedaitely sequester the recalled devices and do not use them during surgery; 3) if the devices have been further distributed, inform them of the recall; and, 4) replacement devices will be provided. Customers with questions can contact Medacta USA at 805-910-6511.
Quantity in Commerce 32 oblique handles
Distribution Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
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 = MAX and Original Applicant = MEDACTA INTERNATIONAL
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