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 |
| Similar To |