K2M, Inc. Recall 90462
Description: Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
K2M, Inc. Recall 90462 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1307-2022 |
| Event ID | 90462 |
| Event Description | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. |
| Product Type | Devices |
| Distribution | Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong. |
| Quantity | 53 devices (19 US; 34 OUS) |
| Recall Reason | Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue. |
| Device Classification | 20220706 |
| Device Code Info | UDI-DI: 10888857326804 Lot PCMW |
| Center Classification Date | 20220630 |
| Recall Initiation Date | 20220613 |
| Recalling Firm | K2M, Inc. |
| Initial Notification | Letter |
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