Device product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Z-1307-2022
Product summary
- Firm
- K2M, Inc.
- Event
- Event 90462
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 devices (19 US; 34 OUS)
- Official record key
device-enforcement:Z-1307-2022
Official wording
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.
Code information: UDI-DI: 10888857326804 Lot PCMW
Distribution pattern: Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Derived failure modes
-
Unknown
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.