FDA recall Z-2706-2020

Richard Wolf GmbH · Class II · device

Product

Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

Reason for recall

Tube material of a smaller diameter was used.

Distribution

International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).

Key facts

Status
Terminated
Initiation date
2020-06-05
Report date
2020-08-05
Termination date
2024-06-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knittlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2706-2020