K2M, Inc Recall 89522
Description: Everest MI XT Inner Dilator, Catalog Number 5101-90167
K2M, Inc Recall 89522 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0705-2022 |
Event ID | 89522 |
Event Description | Everest MI XT Inner Dilator, Catalog Number 5101-90167 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide. |
Quantity | 686 Total Devices |
Recall Reason | Stryker 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 Classification | 20220309 |
Device Code Info | GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK |
Center Classification Date | 20220301 |
Recall Initiation Date | 20220113 |
Recalling Firm | K2M, Inc |
Initial Notification | Letter |
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