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Lower risk Medical device recall · FDA · Published March 25, 2022

Arthrex K-Wire 1.35mm x 170mm: Incorrect Size Risk

Arthrex recalls 1.35mm x 17:00mm K-Wire products that don't meet size specs. Affected items have specific part numbers and batch codes. Consumers should check their product details.

🇺🇸 FDA recall #Z-1035-2022Medical deviceArthrex ›
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Recalling firmArthrex, Inc.1370 Creekside Blvd · Naples, FL 34108-1945
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arthrex is recalling K-Wire products that don't meet the correct size specifications. This could lead to improper use in medical procedures if the wire is too small or too large. Read more at govinfonow.com/recall/60888-arthrex-k-wire-1-35mm-x-170mm-incorrect-size-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60888-arthrex-k-wire-1-35mm-x-170mm-incorrect-size-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1035-2022

Cite this page

“Arthrex K-Wire 1.35mm x 170mm: Incorrect Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60888-arthrex-k-wire-1-35mm-x-170mm-incorrect-size-risk. Based on FDA recall #Z-1035-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1035-2022%22&limit=1).

Why it’s dangerous

The K-Wire products are manufactured to incorrect lengths and diameters. This could cause improper placement during medical procedures, potentially leading to complications if the wire is too small or too large.

Who’s affected

Medical professionals who use K-Wire for procedures may be affected. Patients using these products for treatments are at risk if the incorrect size causes complications.

How to tell if you have this one

Check for part number AR-8610K-43 and batch code 1298116640 on the product. The unique device identifier (UDI) 00888867197084 is also associated with this recall.

  • Brand
    Arthrex
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for part number AR-8610K-43 and batch code 1298116640 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Iowa, Louisiana, Missouri, New York, Ohio, Oregon, Pennsylvania, Tennessee.

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

1. Firm started the recall: Mar 25, 202212. FDA classified it Class II: May 5, 202223. Published in FDA’s Enforcement Report: May 11, 202234. FDA terminated the recall: May 15, 2026420222026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1035-2022 (March 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1035-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA