Z-0931-2021Class II

Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System

Name: Z-0931-2021 Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Creator: K2M, Inc
Published: 2020-12-14
License: https://open.fda.gov/license/

K2M, Inc / initiated 2020-12-14 / Terminated / root cause: manufacturing process

FDA source

K2M, Inc began a recall of Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System on 2020-12-14. FDA classified it as Class II and gives the reason as "The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length)". 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-0931-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Posted: 2021-01-27
Terminated: 2023-07-11
Recalling firm: K2M, Inc
Product: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Product code: NKG Posterior Cervical Screw System
Reason for recall: The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 248 units/1 each
Distribution: Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Product codes and lots: Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-27

Product code NKG

K171444Class IIYUKON OCT Spinal SystemK2m, Inc. / cleared 2017-08-08

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)