YUKON OCT Spinal System recallZ-0931-2021 · K2M, Inc · initiated Dec 14, 2020
Terminated
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
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
FDA root cause category: Employee error
What the company is doing
On 12/14/2020, Stryker Spine US Field Operations were notified of the action by teleconference and e-mail and instructed to identify and return all Lot KRBX screws to Stryker Spine. Affected Stryker Branches/Agencies, and hospitals that had previously been consigned product, will be issued a formal recall notification letter and product return documentation.
Recall details
- Recall number
- Z-0931-2021
- Status
- Terminated
- Initiated by the company
- Dec 14, 2020
- Posted by the FDA
- Jan 27, 2021
- Recalling firm
- K2M, Inc
- Quantity
- 248 units/1 each
- Product code
- NKG
- FDA submissions
- K171444
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Product description
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Code information (models, lots, serial numbers)
Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
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 7601-04026VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall2 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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