Recall Z-2518-2023— Aesculap Implant Systems LLC

Name: FDA recall Z-2518-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-20

Class II · Ongoing

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2023-07-20. It names one FDA 510(k) clearance: K983365. Product: For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R. Reason: Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-07-20
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

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Reason for recall

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

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