Z-0062-2019Class III

Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert...

Name: Z-0062-2019 Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert...
Creator: Dannoritzer Medizintechnik GmbH & Co. KG
Published: 2018-08-06
License: https://open.fda.gov/license/

Dannoritzer Medizintechnik GmbH & Co. KG / initiated 2018-08-06 / Terminated / root cause: labeling and UDI

FDA source

Dannoritzer Medizintechnik GmbH & Co. KG began a recall of Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or... on 2018-08-06. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0062-2019
Classification: Class III
Status: Terminated
Initiated: 2018-08-06
Posted: 2018-10-03
Terminated: 2019-07-22
Recalling firm: Dannoritzer Medizintechnik GmbH & Co. KG
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: In July 2017, Dannoritzer Medizintechnik GmbH & Co. KG issued emails to customers notifying them that an updated Instructions For Use (IFU) manual would be distributed by July 27, 2018. On August 8, 2018, Dannoritzer Medizintechnik GmbH & Co. KG issued Urgent Medical Device Field Correction notices dated August 6, 2018 to customers along with an updated IFU. Customers were encouraged to immediately remove from their place of use and destroy the existing original DANmed Laparoscopy Instruments IFU as well as any copies and replace them with the revised version (V.2018-08-03) included with the notice. Distributors or those who have further distributed the product, please provide those customers with a copy of the notice and revised IFU. Customers are also encouraged to complete and return the Confirmation Card and email to [email protected] Customers with questions may contact Stefan Rauch 011-49-7461-9623915 8 am - 12 PM, EST or email [email protected]
Distribution: US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.
Product codes and lots: none

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0062-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0062-2019	Class III	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code GEI

K052759Class IIDan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG / cleared 2006-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)