Z-2118-2020 Class II Terminated
FDA device recall Z-2118-2020 was initiated by Clinical Innovations, LLC on May 30, 2019 and is designated Class II. Reason for recall: An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surger… The recall status is terminated (terminated August 24, 2020). Affected quantity: 280 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- May 30, 2019
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 devices
Product Description
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled.
Reason for Recall
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
Distribution Pattern
International distribution to the country Japan.
Code Information
Model Number: UM750 Lot Number: 181183