K2M, Inc Recall 87565
Description: Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
K2M, Inc Recall 87565 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1410-2021 |
| Event ID | 87565 |
| Event Description | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033 |
| Product Type | Devices |
| Distribution | PA |
| Quantity | 1 unit |
| Recall Reason | Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies |
| Device Classification | 20210421 |
| Device Code Info | Lot Number: MNAJ GTIN: 10888857082571 |
| Center Classification Date | 20210412 |
| Recall Initiation Date | 20210316 |
| Recalling Firm | K2M, Inc |
| Initial Notification | Letter |
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