Recall Z-1307-2022
K2M, Inc. · initiated June 13, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Codes / lots: UDI-DI: 10888857326804 Lot PCMW
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.
FDA-determined cause: Under Investigation by firm
Action taken
On June 13, 2022, the firm distributed Medical Device Recall letters to affected customers. Customers were informed that local Stryker Sales Representative or Stryker Branch or Agency has already removed any product still located in customer facilities at the time of the initiation of the removal. If you have any questions or concerns, please contact Regulatory Compliance at 201.749.8090.
Details
- Recall number
- Z-1307-2022
- Initiated
- June 13, 2022
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 53 devices (19 US; 34 OUS)
- Distribution
- Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
- Recalling firm
- K2M, Inc., Leesburg, VA