K2M, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1307-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

Product Classification:

Class II

Date Initiated: June 13, 2022

Date Posted: July 6, 2022

Recall Number: Z-1307-2022

Event ID: 90462

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.

Status: Ongoing

Product Quantity: 53 devices (19 US; 34 OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated