Recall Z-1814-2017
Aesculap Implant Systems LLC · initiated March 7, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Item # FH620R
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1814-2017
- Initiated
- March 7, 2017
- Posted by FDA
- March 20, 2017
- Terminated
- February 16, 2018
- Product code
- GWG – Endoscope, Neurological
- Quantity
- 21 units distributed in U.S.
- Distribution
- Product was distributed throughout the United States and Canada.
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA