Z-0520-2021Class II

Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube -

Name: Z-0520-2021 Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube -
Creator: K2M, Inc
Published: 2020-11-03
License: https://open.fda.gov/license/

K2M, Inc / initiated 2020-11-03 / Terminated / root cause: manufacturing process

FDA source

K2M, Inc began a recall of Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to... on 2020-11-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0520-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Posted: 2020-12-02
Terminated: 2021-01-12
Recalling firm: K2M, Inc
Product: 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.
Product code: NKG Posterior Cervical Screw System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 4 devices
Distribution: US Nationwide distribution.
Product codes and lots: Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0520-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0520-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-02

Product code NKG

K193129Class IIYukon OCT Spinal SystemK2m, Inc. / cleared 2020-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)