Z-1814-2017 Class II Terminated
FDA device recall Z-1814-2017 was initiated by Aesculap Implant Systems LLC on March 7, 2017 and is designated Class II. 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 electrod… The recall status is terminated (terminated February 16, 2018). Affected quantity: 21 units distributed in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- February 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units distributed in U.S.
Product Description
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.
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.
Distribution Pattern
Product was distributed throughout the United States and Canada.
Code Information
Item # FH620R