| Class 2 Device Recall Algovita Stimulator | |
Date Initiated by Firm | January 26, 2016 |
Date Posted | March 18, 2016 |
Recall Status1 |
Terminated 3 on April 05, 2017 |
Recall Number | Z-1193-2016 |
Recall Event ID |
73150 |
PMA Number | P130028 |
Product Classification |
Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
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Product | Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel) |
Code Information |
Serial Numbers: 03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07, 03EE08, 03EE0A, 03EE0D, 03EE0E, 03EE12, 03EE13, 03EE1A, 03EE30, 03EE3C, 03EE3F, 03EE44, 03EE48, 03EE4C, 03EE4D, 03EE6D, 03EE74, 03EE82, 03EE88, 03EE89, 03EE8F, 03EE94. |
Recalling Firm/ Manufacturer |
QiG Group LLC 10675 Naples St NE Blaine MN 55449-5802
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Manufacturer Reason for Recall | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms. |
Quantity in Commerce | 34 |
Distribution | Distributed in Germany and Luxembourg. |
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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PMA Database | PMAs with Product Code = LGW
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