Recall Z-0062-2019— Dannoritzer Medizintechnik GmbH & Co. KG

Name: FDA recall Z-0062-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-06

Class III · Terminated

Class III FDA medical device recall by Dannoritzer Medizintechnik GmbH & Co. KG, initiated 2018-08-06, terminated 2019-07-22. It names one FDA 510(k) clearance: K052759. Product: Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation. Reason: The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability..

Recalling firm: Dannoritzer Medizintechnik GmbH & Co. KG
Classification: Class III
Status: Terminated
Initiated: 2018-08-06
Terminated: 2019-07-22
Firm location: Tuttlingen, Germany

510(k) clearances named in this recall

1 on FDA's record

K052759 — DAN MONOPOLAR LAP ACCESSORIESDannoritzer Medizintechnik GmbH & Co. KG·cleared 2006-06-14

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

Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

Reason for recall

The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

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