Product Safety Recalls

Product Recall Tracker

K2M, Inc Recall 89522

Description: Everest MI XT Inner Dilator, Catalog Number 5101-90167

K2M, Inc Recall 89522 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0705-2022
Event ID89522
Event DescriptionEverest MI XT Inner Dilator, Catalog Number 5101-90167
Product TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity686 Total Devices
Recall ReasonStryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Device Classification20220309
Device Code InfoGTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
Center Classification Date20220301
Recall Initiation Date20220113
Recalling FirmK2M, Inc
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.