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U.S. Department of Health and Human Services

Class 2 Device Recall M.U.S.T. Rod

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  Class 2 Device Recall M.U.S.T. Rod see related information
Date Initiated by Firm December 07, 2016
Date Posted January 13, 2017
Recall Status1 Terminated 3 on November 15, 2017
Recall Number Z-1023-2017
Recall Event ID 76034
510(K)Number K121115  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo

The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
Code Information Lot #s 125212,144216, 148146
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall		 Damaged packaging, lack of sterility assurance
FDA Determined
Cause 2		 Packaging
Action The firm, Medacta International, immediately notified all customers by phone on 12/07/16 and further notified via email on 12/9/16. The firm also issued an "URGENT- Field Safety Notice" dated 7/12/2016 to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to return all units to Medacta International SA and forward the notice to all people and organizations potentially affected. If you have any questions contact Regulatory Affairs Manager at +41 (0) 91 696 60 60.
Quantity in Commerce 82 units
Distribution Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
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 = KWP and Original Applicant = MEDACTA INTERNATIONAL
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