CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report

Yukon Polyaxial Screw Size 4.0x26mm recalled by K2M

K2M is recalling Yukon Polyaxial Screw Size 4.0x26mm (, distributed nationwide in the US. The recall was initiated on 14 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

Quantity recalled248 units/1 each

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0931-2021
FDA event ID: 87075
Recalling firm: K2M, Leesburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2020
FDA classified: 27 Jan 2021
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

14 Dec 2020	Recall initiated by company
27 Jan 2021	Classified by FDA	+44 days
3 Feb 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore

Nationwide

Questions about this recall

Why was it recalled?

The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).

Which lots are affected?

Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582

Where was it sold?

Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from K2M

All 39

Reported	Class	Recall	Company	Reason	Where
6 Jul 2022Device	CLASS II	Yukon Straight Rod recalled by K2M	K2M	Other	6 states
9 Mar 2022Device	CLASS II	Everest MI XT Outer Dilator recalled by K2M	K2M	Other	Nationwide
9 Mar 2022Device	CLASS II	Everest MI XT Inner Dilator recalled by K2M	K2M	Other	Nationwide
20 Oct 2021Device	CLASS II	Chesapeake Anterior Lumbar (AL) Removal Tool recalled by K2M	K2M	Other	9 states
9 Jun 2021Device	CLASS II	Cascadia AN Interbody Convex 10x22x14mm recalled by K2M	K2M	Labeling Errors	Nationwide

Other Spinal Implants recalls

All 1,161

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide