Clinical Innovations recalls UM750 uterine manipulators due to incorrect component causing potential surgery delays. Affected units have lot 181183. Contact for remedy details.
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.
Clinical Innovations is recalling their Clearview Total Uterine Manipulator model UM750 because a manufacturing error means the device might not attach properly. This could cause surgery delays or extra procedures. There was a report of an injury.
The uterine manipulator tip support lacks the required "notch" to attach the spacer or colpotomy cup. This can cause the device to not function properly during surgery, potentially requiring additional procedures or delaying the surgery. A report of an injury was documented.
Surgical teams using the Clearview Total Uterine Manipulator model UM750 with lot number 181183 are affected. Patients undergoing gynecological procedures are at risk if the device fails during surgery.
Check for the model number UM750 and lot number 181183 on the device. The device is labeled with "ClearView(R) TOTAL, 7 cm* *".
Look for the model number UM750 and lot number 181183 on the device label.
The device may not function properly due to a manufacturing error, which could cause surgery delays or additional procedures. It is not safe to use as is.
Check the device label for model number UM750 and lot number 181183. Contact Clinical Innovations for remedy details.
A report of an injury was documented, but the recall does not specify the severity of injuries.
We’ve drafted a message you can send Clinical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-2118-2020 — Clinical Innovations Clinical Innovations Hello, I own a Clinical Innovations that is covered by recall Z-2118-2020 from Clinical Innovations. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
