Recall Z-1814-2017— Aesculap Implant Systems LLC

Name: FDA recall Z-1814-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-07

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2017-03-07, terminated 2018-02-16. It names one FDA 510(k) clearance: K983365. 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.. Reason: 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..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Terminated: 2018-02-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K983365 — AESCULAP MINOP SYSTEMAesculap, Inc.·cleared 1998-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.