Recall Z-2118-2020 ยท LKF Cannula, Manipulator/Injector, Uterine
Clinical Innovations, LLC
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.
| Date | May 30, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 sa |
| Quantity | 280 devices |
| Distribution | International distribution to the country Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131781 | CLEARVIEW TOTAL Clinical Innovations, LLC, May 28, 2014 |