medical Class II Updated 2020-06-03

Clinical Innovations, LLC recalls Clearview Total Uterine Manipulator (model UM750), The devi

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: International distribution to the country Japan.
Lot/Code Info: Model Number: UM750 Lot Number: 181183
View official government recall

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