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.
This recall has been terminated (originally issued May 30, 2019).
- Company
- Clinical Innovations, Llc
- Recall Initiated
- May 30, 2019
- Terminated
- August 24, 2020
- Recall Number
- Z-2118-2020
- Quantity
- 280 devices
- Firm Location
- Murray, UT
- Official Source
- View on FDA website ↗
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
International distribution to the country Japan.
Lot / Code Info
Model Number: UM750 Lot Number: 181183
Root Cause
Process control
Action Taken
On July 2, 2019, the firm sent an field Safety Notice letter to consignees. In addition to informing consignees about the recall they asked that the following actions be taken: 1. Please provide the field safety notice to your hospitals. If you have further distributed this product, please identify your customers and notify them at once of this communication and/or contact Clinical Innovations with the contact information s that we can follow-up with the owner of the device. 2. Please quarantine any remaining product in your hospitals and completed the response card attached to this filed safety notice. A company representative will contact you and arrange for the return of the product. 3. If you have any questions, please call Clinical Innovations at 1-8880268-6222, M-F, 8:00 Am 5:00 PM MT