Lower risk Medical device recall · FDA · Published July 24, 2018

K2M YUKON Polyaxial Screws Recall: Manufacturing Error Prevents Proper Function

K2M recalls YUKON Polyaxial Screws (3.5 X 12 mm to 5.0 X 30 mm) due to a manufacturing error that may prevent screws from mating with inserters. This affects medical devices sold in the U.S. since 2018.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0110-2020Medical device K2M ›

Lower-risk recall

Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.

Take action

Contact the company

Recalling firmK2M, Inc600 Hope Pkwy SE · Leesburg, VA 20175-4428

✎ GovInfoNow plain-language explainer

K2M is recalling YUKON Polyaxial Screws that have a manufacturing error preventing them from properly mating with screw inserters. This could lead to improper use in medical procedures if the screws don't function as intended. Read more at govinfonow.com/recall/70300-k2m-yukon-polyaxial-screws-recall-manufacturing-error-prevents-proper-function.

Source Summary by GovInfoNow · govinfonow.com/recall/70300-k2m-yukon-polyaxial-screws-recall-manufacturing-error-prevents-proper-function · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0110-2020

Cite this page

“K2M YUKON Polyaxial Screws Recall: Manufacturing Error Prevents Proper Function.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70300-k2m-yukon-polyaxial-screws-recall-manufacturing-error-prevents-proper-function. Based on FDA recall #Z-0110-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2020%22&limit=1).

The FDA announced on July 24, 2018, that K2M, Inc. voluntarily recalled YUKON Polyaxial Screws due to a manufacturing error that could prevent proper mating with insertion tools. The agency issued recall number Z-0110-2020 for the Class II device.

How to tell if you have it

Brand: K2M
Product: YUKON Polyaxial Screws
Sizes: 3.5 X 12 mm, 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm
Catalog Numbers: 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028, 7601-05030
Lot Codes: FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL, FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV
Distribution: Accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and Australia

The hazard

According to the FDA, the screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to the FDA as part of Stryker's retrospective review of K2M product field actions.

Context

GovInfoNow's records show K2M, Inc. has had 10 other recalls since April 18, 2019. On June 13, 2022, the company recalled Yukon Straight Rods due to a mild irritation risk from phosphorous. On January 13, 2022, K2M issued a recall for Everest MI XT Outer Dilators because of improper fit during surgery. Other recent recalls of similar products include Tornier Perip Screw Recall (Dec. 19, 2025) and Synthes 2.4V TAP CORTEX SCREW Recall (Feb. 25, 2026).

How to tell if you have this one

Check for YUKON Polyaxial Screws with sizes 3.5 X 12 mm to 5.0 X 30 mm. The catalog numbers include 7601-03512 through 7601-05030. These were sold in the U.S. starting in 2018 with lots labeled FUVD through FUXV.

Brand
K2M
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your screws match the listed sizes and catalog numbers (e.g., 3.5 X 12 mm, 7601-03512).

Where it went and when

Where it was distributed

Distributed in 20 states, and outside the U.S.

FDA distribution: “Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Jul 24, 2018Firm started the recall
Oct 9, 2019FDA classified it Class II
Oct 16, 2019Published in FDA’s Enforcement Report
Oct 1, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have these screws?

The recall does not include a remedy, so no action is required beyond checking if your screws match the listed specifications.

Similar recalls

Latest medical device recalls

Keep exploring

More K2M recalls

Link to this recall

<a href="https://govinfonow.com/recall/70300-k2m-yukon-polyaxial-screws-recall-manufacturing-error-prevents-proper-function">K2M YUKON Polyaxial Screws Recall: Manufacturing Error Prevents Proper Function (GovInfoNow)</a>

Where this comes from

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-0110-2020 (July 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0110-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.