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Recall Observatory FDA recall evidence

Device 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

Z-0062-2019

August 06, 2018

Class III

Product summary

Firm
Dannoritzer Medizintechnik GmbH & Co. KG
Event
Event 80970
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
device-enforcement:Z-0062-2019

Official wording

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.

Code information: none

Distribution pattern: US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.