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U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Trial Lead Kits

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  Class 2 Device Recall Percutaneous Trial Lead Kits see related information
Date Initiated by Firm July 29, 2014
Date Posted September 29, 2014
Recall Status1 Terminated 3 on August 21, 2015
Recall Number Z-2718-2014
Recall Event ID 69025
510(K)Number K123299  
Product Classification Stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
Product Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead).

Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Code Information Material 100077113, Batch 4558337
Recalling Firm/
Manufacturer		 St. Jude Medical, Inc.
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact Mark Neal
972-309-2154
Manufacturer Reason
for Recall		 The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
FDA Determined
Cause 2		 Packaging process control
Action A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.
Quantity in Commerce 2 units
Distribution Distributed in the states of Texas and Illinois.
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 = GZB and Original Applicant = ST. JUDE MEDICAL NEUROMODULATION
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