Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) ...
FDA Device Recall #Z-2118-2020 — Class II — May 30, 2019
Recall Summary
| Recall Number | Z-2118-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 30, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Clinical Innovations, LLC |
| Location | Murray, UT |
| Product Type | Devices |
| Quantity | 280 devices |
Product Description
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.
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 Pattern
International distribution to the country Japan.
Lot / Code Information
Model Number: UM750 Lot Number: 181183
Other Recalls from Clinical Innovations, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0541-2021 | Class II | Clinical Innovations ROM Plus Collection Kit ... | Aug 13, 2020 |
| Z-2072-2020 | Class II | Kiwi Complete Vacuum Delivery System, Model No.... | Aug 6, 2019 |
| Z-0123-2016 | Class II | The Ebb Complete Tamponade System, model #CTS-1... | Jan 5, 2015 |
| Z-1014-2015 | Class II | Ebb Complete Tamponade System, BD-OTS Obstetric... | Dec 30, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.