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U.S. Department of Health and Human Services

Class 2 Device Recall Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.

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  Class 2 Device Recall Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc. see related information
Date Initiated by Firm April 07, 2015
Date Posted June 22, 2015
Recall Status1 Terminated 3 on October 01, 2015
Recall Number Z-1823-2015
Recall Event ID 71357
510(K)Number K120832  
Product Classification Orthosis, spondylolisthesis spinal fixation - Product Code MNH
Product Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Code Information Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
Recalling Firm/
Manufacturer		 X Spine Systems Inc
452 Alexandersville Rd
Miamisburg OH 45342-3658
For Additional Information Contact Mr. Kriss E. Anderson
937-847-8400 Ext. 137
Manufacturer Reason
for Recall		 The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
FDA Determined
Cause 2		 Other
Action X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.
Quantity in Commerce 75 units
Distribution Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
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 = MNH and Original Applicant = X-SPINE SYSTEMS, INC
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