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Lower risk Medical device recall · FDA · Published December 3, 2021

Wright Medical Charlotte MTP Hex Screw Recall: Incorrect Product in Packaging

Wright Medical recalls Charlotte MTP Hex Screw Model 411: Incorrect product in packaging. Affected units sold with specific lot numbers. Contact for replacement.

🇺🇸 FDA recall #Z-0401-2022Medical deviceWright Medical ›
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Recalling firmWright Medical Technology, Inc.1023 Cherry Rd · Memphis, TN 38117-5423
✎ GovInfoNow plain-language explainer

What happened, in plain English

Wright Medical is recalling a specific screw component due to incorrect product being packaged. This could lead to improper use in medical procedures if the wrong screw is installed. Read more at govinfonow.com/recall/61472-wright-medical-charlotte-mtp-hex-screw-recall-incorrect-product-in.

Source Summary by GovInfoNow · govinfonow.com/recall/61472-wright-medical-charlotte-mtp-hex-screw-recall-incorrect-product-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0401-2022

Cite this page

“Wright Medical Charlotte MTP Hex Screw Recall: Incorrect Product in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61472-wright-medical-charlotte-mtp-hex-screw-recall-incorrect-product-in. Based on FDA recall #Z-0401-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2022%22&limit=1).

Why it’s dangerous

The packaging contains the wrong screw model, which could be installed incorrectly during surgery. This might cause improper fixation of the foot, potentially leading to complications.

Who’s affected

Medical professionals using the Charlotte MTP Hex Screw component in Lisfranc Reconstruction Systems. Patients receiving this component during surgery are at risk if the wrong screw is used.

How to tell if you have this one

Check for model #41122718, 2.7mm x 18mm, with lot numbers 02010697711582590 or 02010697711582591. The screw is part of the Charlotte Lisfranc Reconstruction System.

  • Brand
    Wright Medical
  • Product
    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number and lot numbers to confirm if your screw is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Iowa, South Carolina.

Recall timeline

FDA published this recall 26 days after the firm started it.

1. Firm started the recall: Dec 3, 202112. FDA classified it Class II: Dec 20, 202123. Published in FDA’s Enforcement Report: Dec 29, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Is this product dangerous if used correctly?

The recall is due to incorrect packaging, not inherent danger. If used correctly, the product is safe.

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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-0401-2022 (December 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0401-2022 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