Clinical Innovations, LLC: Medical Device Recall in 2020 - (Recall #: Z-2118-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
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.
Model Number: UM750 Lot Number: 181183
International distribution to the country Japan.
Voluntary: Firm initiated