Z-2118-2020Class II

Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm*...

Name: Z-2118-2020 Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm*...
Creator: Clinical Innovations, LLC
Published: 2019-05-30
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2019-05-30 / Terminated / root cause: manufacturing process

FDA source

Clinical Innovations, LLC began a recall of Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical... on 2019-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2118-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-30
Posted: 2020-05-26
Terminated: 2020-08-24
Recalling firm: Clinical Innovations, LLC
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 is similarly labeled.
Product code: LKF Cannula, Manipulator/Injector, Uterine
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.
Root cause tag: manufacturing process
FDA 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 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
Quantity in commerce: 280 devices
Distribution: International distribution to the country Japan.
Product codes and lots: Model Number: UM750 Lot Number: 181183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2118-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2118-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code LKF

K131781Class IIClearview TotalClinical Innovations, LLC / cleared 2014-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)