Date Initiated by Firm | July 29, 2014 |
Date Posted | September 29, 2014 |
Recall Status1 |
Terminated 3 on August 21, 2015 |
Recall Number | Z-2719-2014 |
Recall Event ID |
69025 |
510(K)Number | K123299 |
Product Classification |
Stimulator, spinal-cord, implanted (pain relief) - Product Code GZB
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Product | Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead).
Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. |
Code Information |
Material 100077108, Batch 4519182 |
Recalling Firm/ Manufacturer |
St. Jude Medical, Inc. 6901 Preston Rd Plano TX 75024-2508
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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 | 4 units |
Distribution | Distributed in the states of Texas and Illinois. |
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 = GZB
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