Lower riskMedical device recall · FDA · Published December 14, 2020
K2M Yukon Spinal Screw Recall: Incorrect Laser Marking May Cause Misuse
K2M recalls Yukon Polyaxial Screw Size 4.0x26mm (catalog 7601-04026) due to incorrect laser marking. This may lead to improper spinal surgery use. Affected units have lot number KRBX.
“K2M Yukon Spinal Screw Recall: Incorrect Laser Marking May Cause Misuse.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63667-k2m-yukon-spinal-screw-recall-incorrect-laser-marking-may-cause. Based on FDA recall #Z-0931-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0931-2021%22&limit=1).
K2M, Inc. recalled Yukon Polyaxial Screws Size 4.0x26mm because they were incorrectly laser marked with size 5.0 mm diameter and 24 mm length, the FDA said on Dec. 14, 2020. The recall involves 248 units distributed domestically and in Australia, Canada, the Netherlands, and Singapore.
How to tell if you have it
Brand: K2M
Product: Yukon Polyaxial Screw Size 4.0x26mm
Catalog number: 7601-04026
Lot code: KRBX
Product Code (UDI): 10888857349582
The hazard
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm diameter and 24 mm length, according to the FDA.
Context
GovInfoNow's records show K2M, Inc. has had 10 other recalls since July 24, 2018. Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025), the Prodisc C SK Product Recall (Dec. 31, 2025), and the XTANT Medical Xpress Pedicle Screw System recall (Feb. 18, 2026).
How to tell if you have this one
Check for the catalog number 7601-04026 on the screw packaging or label. Affected units have lot number KRBX. This screw is part of the YUKON Spinal System.
Brand
K2M
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the catalog number 7601-04026 and lot number KRBX on the screw packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall indicates the screw was incorrectly marked, which could lead to improper surgical use if the wrong size is selected. However, the hazard is not described as causing immediate injury or death in normal use.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0931-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0931-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.