| Class 2 Device Recall Integra Life Sciences Ojemann Cortical Stimulator | |
Date Initiated by Firm | March 18, 2013 |
Date Posted | April 01, 2013 |
Recall Status1 |
Terminated 3 on February 25, 2014 |
Recall Number | Z-1030-2013 |
Recall Event ID |
64665 |
510(K)Number | K924226 |
Product Classification |
Electrode, cortical - Product Code GYC
|
Product | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2.
Intended for intraoperative cortical stimulation mapping procedures. |
Code Information |
Serial Number Range: 1010 through 1380 |
Recalling Firm/ Manufacturer |
Integra Burlington MA, Inc. 22 Terry Ave Burlington MA 01803-2516
|
For Additional Information Contact | Same 781-272-1233 |
Manufacturer Reason for Recall | If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury. |
FDA Determined Cause 2 | Device Design |
Action | Integra initiated a voluntary recall on March 18, 2013 by providing written notification to consignees either by traceable courier service or traceable emails regarding the correction that Integra records indicate have an OCS2 since it was introduced to the market in 2007. The consignee notification:
Advised of the nature of the issue and to immediately stop using the headphone jack while using the OCS2. Requested identification by S/N any OCS2's they have, and complete / return the Acknowledgment Return Form.
Advised that Integra will contact the consignee to schedule a time / date to correct the OCS2's they have identified. Questions, contact service hotline at 1-888-772-7378. |
Quantity in Commerce | 371 units |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa. |
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 = GYC
|
|
|
|