FDA Medical Device Recalls (openFDA)
Dannoritzer Medizintechnik GmbH & Co. KG: 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
- Recall number
- Z-0062-2019
- 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
- Status
- Terminated
- Initiated
- 2018-08-06
- Posted
- not on file
- Terminated
- 2019-07-22
- 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.
- 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 notification@danrepair.de Customers with questions may contact Stefan Rauch 011-49-7461-9623915 8 am - 12 PM, EST or email notification@danrepair.de
- Quantity
- not on file
- Distribution
- US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.
- Lot, serial or model codes
- none
- 510(k) numbers
- ["K052759"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000482681
- Firm city
- Tuttlingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28