Date Initiated by Firm | April 17, 2009 |
Date Posted | May 07, 2013 |
Recall Status1 |
Terminated 3 on May 07, 2013 |
Recall Number | Z-1257-2013 |
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 40mm Straight Rod,
Part Number: 60101-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. |
Code Information |
Lot Number: 080593 |
Recalling Firm/ Manufacturer |
Spinal Elements, Inc 3115 Melrose Dr Suite 200 Carlsbad CA 92010-6690
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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 |
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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 = NKB
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