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U.S. Department of Health and Human Services

Class 3 Device Recall Mercury Spinal System DIA 5.5 x 80mm Straight Rod

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  Class 3 Device Recall Mercury Spinal System DIA 5.5 x 80mm Straight Rod see related information
Date Initiated by Firm April 17, 2009
Date Posted May 07, 2013
Recall Status1 Terminated 3 on May 07, 2013
Recall Number Z-1261-2013
Recall Event ID 53487
510(K)Number K071914  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Mercury Spinal System DIA 5.5 x 80mm Straight Rod,
Part Number: 60101-080.

Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code Information Lot Number: 080597
Recalling Firm/
Manufacturer
Spinal Elements, Inc
3115 Melrose Dr
Suite 200
Carlsbad CA 92010-6690
For Additional Information Contact
760-607-0121 Ext. 206
Manufacturer Reason
for Recall
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.
Quantity in Commerce 68 units total
Distribution Distributed in OH and PA.
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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