Date Initiated by Firm | March 07, 2017 |
Date Posted | March 20, 2017 |
Recall Status1 |
Terminated 3 on February 16, 2018 |
Recall Number | Z-1814-2017 |
Recall Event ID |
76769 |
510(K)Number | K983365 |
Product Classification |
Endoscope, neurological - Product Code GWG
|
Product | AESCULAP MINOP InVent 30 Trocar System, non-sterile
Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures. |
Code Information |
Item # FH620R |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
|
For Additional Information Contact | Valerie Strawn 610-984-9414 Ext. 5414 |
Manufacturer Reason for Recall | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc. |
Quantity in Commerce | 21 units distributed in U.S. |
Distribution | Product was distributed throughout the United States and Canada. |
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 = GWG
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