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Lower risk Medical device recall · FDA · Published January 28, 2022

Brasseler K-WIRE Double Trocar Smooth Recall: Unsealed Packaging Hazard

Brasseler USA recalls K-WIRE Double Trocar Smooth (Lot NV1MX) due to unsealed packaging. Consumers should check product labels for the lot code to determine if affected.

🇺🇸 FDA recall #Z-0707-2022Medical deviceBrasseler USA ›
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Contact the company

Recalling firmBrasseler USA, Medical L.L.C.1 Brasseler Blvd · Savannah, GA 31419-9576
✎ GovInfoNow plain-language explainer

What happened, in plain English

Brasseler USA is recalling a specific lot of K-WIRE Double Trocar Smooth surgical devices because they were distributed in unsealed packaging. This could lead to contamination or improper handling if the packaging is not sealed properly. Read more at govinfonow.com/recall/61209-brasseler-k-wire-double-trocar-smooth-recall-unsealed-packaging-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/61209-brasseler-k-wire-double-trocar-smooth-recall-unsealed-packaging-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0707-2022

Cite this page

“Brasseler K-WIRE Double Trocar Smooth Recall: Unsealed Packaging Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61209-brasseler-k-wire-double-trocar-smooth-recall-unsealed-packaging-hazard. Based on FDA recall #Z-0707-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0707-2022%22&limit=1).

Why it’s dangerous

The unsealed packaging means the product could be contaminated or improperly handled. This might lead to infection or other complications during medical procedures if the device is not properly protected.

Who’s affected

Surgical device users who own the specific lot (NV1MX) of Brasseler K-WIRE Double Trocar Smooth. Patients and medical staff using this product are at risk if the packaging was compromised.

How to tell if you have this one

Check the product label for the lot code NV1MX. The product is identified by the UDI (01)00887919491033(17)260719(10)NV1MX. This specific lot was distributed in unsealed packaging.

  • Brand
    Brasseler USA
  • Product
    Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the lot code NV1MX on the product label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Florida, Idaho, Illinois, Michigan, Ohio, Pennsylvania, South Carolina, Tennessee, Texas.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Jan 28, 202212. FDA classified it Class II: Mar 1, 202223. Published in FDA’s Enforcement Report: Mar 9, 202234. FDA terminated the recall: Feb 3, 2023420222023
  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-0707-2022 (January 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0707-2022 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