K2M, Inc Recall 88630
Description: Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
K2M, Inc Recall 88630 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0104-2022 |
| Event ID | 88630 |
| Event Description | Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 |
| Product Type | Devices |
| Distribution | Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada. |
| Quantity | 23 |
| Recall Reason | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery. |
| Device Classification | 20211020 |
| Device Code Info | Lots CCUNA, HYMJ, KNCU |
| Center Classification Date | 20211013 |
| Recall Initiation Date | 20210908 |
| Recalling Firm | K2M, Inc |
| Initial Notification | Letter |
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