The Recall Desk
SevereFDA (Devices)·Z-2118-2020·Announced 2020-06-03

Clinical Innovations Recalls Clearview Total Uterine Manipulator Due to Defective Tip Support

Clinical Innovations is recalling 280 Clearview Total Uterine Manipulators (model UM750) because a missing notch on the tip support may prevent proper attachment of surgical components.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that there was a report of an injury, which meets the rubric criteria for a score of 4 (Severe) due to significant injury reports.

Plain-English summary

Clinical Innovations, LLC is recalling 280 units of the Clearview Total Uterine Manipulator, model UM750, lot 181183. The recall was initiated because an incorrect component was used during manufacturing, resulting in a uterine manipulator tip support that lacks the required notch to attach the spacer and/or colpotomy cup.

The affected devices were distributed internationally to Japan. The defect may result in a delay in surgery and additional surgical interventions to complete the procedure. The source text notes that there was a report of an injury associated with this issue.

Healthcare providers and facilities that have received these devices should stop using them and contact Clinical Innovations, LLC for further instructions on the recall process.

The recalled product

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 i
Affected units
280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Number: UM750 Lot Number: 181183

Distribution

Distribution scope not specified by the agency.