Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Check against the official notice below — it lists the full affected range.
K2M, Inc. is recalling Yukon Straight Rod 4.0 x120mm devices (Cat# 7601-540120) used for spinal immobilization and stabilization. Some rods in lot PCMW were found to have discoloration indicating trace amounts of inorganic phosphorous compound. This contamination may cause mild irritation or inflammatory responses, and adverse local tissue reactions related to damage to tissue cells may occur between the affected rod and surrounding tissue.
The recall affects 53 total devices: 19 distributed in the United States (Florida, Georgia, Nebraska, Nevada, New York, Ohio, Oklahoma, and South Carolina) and 34 distributed outside the U.S. to Canada, the European Union, and Hong Kong. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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) Lot/code info: UDI-DI: 10888857326804 Lot PCMW
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.