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K2M, Inc. recalls Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Recalled July 6, 2022 · FDA recall Z-1307-2022 · K2M
Hazard
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. · FDA Class II
Units
53 devices (19 US; 34 OUS)
Sold at
Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Description
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.
Product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Manufacturer(s)
K2M, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →