Z-2706-2020 Class II Terminated
FDA device recall Z-2706-2020 was initiated by Richard Wolf GmbH on June 5, 2020 and is designated Class II. Reason for recall: Tube material of a smaller diameter was used. The recall status is terminated (terminated June 28, 2024). Affected quantity: 338 sets.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- June 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338 sets
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.
Distribution Pattern
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).
Code Information
Lot Number 32324159, Model # 4170.801