YUKON OCT Spinal System recallZ-1307-2022 · K2M, Inc. · initiated Jun 13, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from K2M, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1307-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 13, 2022
- Recalling firm
- K2M, Inc.
- Quantity
- 53 devices (19 US; 34 OUS)
- Product code
- KWP
- FDA submissions
- K171444
- Distribution
- Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
Product description
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Code information (models, lots, serial numbers)
UDI-DI: 10888857326804 Lot PCMW
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- YUKON OCT Spinal System 7601-540120VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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