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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MNH
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