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K2M, Inc Recall 89522

Description: Everest MI XT Outer Dilator, Catalog Number 5101-90168

K2M, Inc Recall 89522 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0706-2022
Event ID89522
Event DescriptionEverest MI XT Outer Dilator, Catalog Number 5101-90168
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: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Center Classification Date20220301
Recall Initiation Date20220113
Recalling FirmK2M, Inc
Initial Notification Letter
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