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K2M, Inc. Recall 90462

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

K2M, Inc. Recall 90462 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1307-2022
Event ID90462
Event DescriptionYukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Product TypeDevices
DistributionDomestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Quantity53 devices (19 US; 34 OUS)
Recall ReasonSome 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.
Device Classification20220706
Device Code InfoUDI-DI: 10888857326804 Lot PCMW
Center Classification Date20220630
Recall Initiation Date20220613
Recalling FirmK2M, Inc.
Initial Notification Letter
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