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U.S. Department of Health and Human Services

Class 3 Device Recall Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod

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 Class 3 Device Recall Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rodsee related information
Date Initiated by FirmApril 17, 2009
Date PostedMay 07, 2013
Recall Status1 Terminated 3 on May 07, 2013
Recall NumberZ-1251-2013
Recall Event ID 53487
510(K)NumberK071914 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductMercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Code Information Lot number: 080587
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
ActionSpinal 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 Commerce68 units total
DistributionDistributed in OH and PA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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