Recall Z-2706-2020— Richard Wolf GmbH
Class II · Terminated
Class II FDA medical device recall by Richard Wolf GmbH, initiated 2020-06-05, terminated 2024-06-28. It names one FDA 510(k) clearance: K000180. 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: Tube material of a smaller diameter was used..
- Recalling firm
- Richard Wolf GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-05
- Terminated
- 2024-06-28
- Firm location
- Knittlingen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.