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U.S. Department of Health and Human Services

Class 3 Device Recall Mercury Spinal System

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  Class 3 Device Recall Mercury Spinal System see related information
Date Initiated by Firm April 09, 2015
Date Posted May 11, 2015
Recall Status1 Terminated 3 on June 25, 2015
Recall Number Z-1597-2015
Recall Event ID 70950
510(K)Number K071914  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
Code Information Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013
Recalling Firm/
Manufacturer		 Spinal Elements, Inc
3115 Melrose Dr Suite 200
Carlsbad CA 92010-6690
For Additional Information Contact Customer Service Department
877-774-6255 Ext. 213
Manufacturer Reason
for Recall		 Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.
Quantity in Commerce 588
Distribution Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
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 = NKB and Original Applicant = SPINAL ELEMENTS, INC.
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