YUKON OCT Spinal System recallZ-0520-2021 · K2M, Inc · initiated Nov 3, 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
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Our records indicate Stryker previously distributed catalog no. 7601-9001, Lot KTGG to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply form found on the following page and return it to the email addresses referenced in the form. If you have any questions or concerns, please contact Stryker Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing the Business Reply Form and returning it to Stryker by November 6th, 2020.
Recall details
- Recall number
- Z-0520-2021
- Status
- Terminated
- Initiated by the company
- Nov 3, 2020
- Recalling firm
- K2M, Inc
- Quantity
- 4 devices
- Product code
- NKG
- FDA submissions
- K193129
- Distribution
- US Nationwide distribution.
Product description
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
Code information (models, lots, serial numbers)
Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
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 7601-90001VB Spine LLC · Orthopedic manual surgical instrument1 recall7 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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