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U.S. Department of Health and Human Services

Class 2 Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm

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  Class 2 Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm see related information
Date Initiated by Firm March 11, 2015
Date Posted April 22, 2015
Recall Status1 Terminated 3 on October 21, 2015
Recall Number Z-1512-2015
Recall Event ID 70774
510(K)Number K120832  
Product Classification Orthosis, spondylolisthesis spinal fixation - Product Code MNH
Product Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Code Information Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
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		 One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.
Quantity in Commerce 14 units
Distribution US Distribution to states of: KS, NV & TX.
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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