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U.S. Department of Health and Human Services

Class 2 Device Recall Cannula, Manipulator/Injector, Uterine

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 Class 2 Device Recall Cannula, Manipulator/Injector, Uterinesee related information
Date Initiated by FirmMay 30, 2019
Create DateMay 26, 2020
Recall Status1 Terminated 3 on August 24, 2020
Recall NumberZ-2118-2020
Recall Event ID 85144
510(K)NumberK131781 
Product Classification Cannula, manipulator/injector, uterine - Product Code LKF
ProductClearview 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.
Code Information Model Number: UM750 Lot Number: 181183
Recalling Firm/
Manufacturer		 Clinical Innovations, LLC
747 W 4170 S
Murray UT 84123-1364
For Additional Information ContactKellie Stefaniak
801-268-8200
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce280 devices
DistributionInternational distribution to the country Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LKF
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