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U.S. Department of Health and Human Services

Class 3 Device Recall DANmed

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 Class 3 Device Recall DANmedsee related information
Date Initiated by FirmAugust 06, 2018
Create DateOctober 03, 2018
Recall Status1 Terminated 3 on July 22, 2019
Recall NumberZ-0062-2019
Recall Event ID 80970
510(K)NumberK052759 
Product Classification Electrosurgical, cutting & coagulation & #38; accessories - Product Code GEI
ProductLaparoscopy 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
Code Information none
FEI Number 1000482681
Recalling Firm/
Manufacturer		 Dannoritzer Medizintechnik GmbH & Co. KG
Sattlerstr. 25
Tuttlingen Germany
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionIn 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 notification@danrepair.de Customers with questions may contact Stefan Rauch 011-49-7461-9623915 8 am - 12 PM, EST or email notification@danrepair.de
DistributionUS Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = GEI
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