FDA-Device2022-07-06Class II
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
K2M, Inc.
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.
Sold states
Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Affected count
53 devices (19 US; 34 OUS)
Manufactured in
600 Hope Pkwy Se, Leesburg, VA, United States
Products
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1307-2022Don't want to check this manually?
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