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Use caution Medical device recall · FDA · Published November 21, 2019

Stry: Pin To Rod Coupling External Fixation System: May Not Clamp Properly

Stryker recalls a pin-to-rod coupling for fracture treatment. The device may not clamp pin and rod as intended, risking improper fixation. Affected units include specific model and lot numbers.

🇺🇸 FDA recall #Z-0781-2020Medical deviceStryker ›
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Recalling firmStryker GmbHBohnackerweg 1 · Selzach, Switzerland
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker is recalling a pin-to-rod coupling used in external fixation systems for fractures. The device may not clamp the pin and rod properly, which could lead to improper treatment and potential complications. Read more at govinfonow.com/recall/66463-stry-pin-to-rod-coupling-external-fixation-system-may-not.

Source Summary by GovInfoNow · govinfonow.com/recall/66463-stry-pin-to-rod-coupling-external-fixation-system-may-not · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0781-2020

Cite this page

“Stry: Pin To Rod Coupling External Fixation System: May Not Clamp Properly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66463-stry-pin-to-rod-coupling-external-fixation-system-may-not. Based on FDA recall #Z-0781-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2020%22&limit=1).

Why it’s dangerous

The pin-to-rod coupling may not clamp the pin and rod as intended. This could result in improper fixation of the fracture, potentially causing pain, displacement, or complications during healing.

Who’s affected

Patients with specific fractures treated using this coupling are affected. Those with distal radius fractures, intercarpal fractures, or unstable forearm fractures are most at risk.

How to tell if you have this one

Check for the model name 'Pin To Rod Coupling 5/3-4mm' with catalog number 4940-1-020. The lot number D30875 and UDI (01)07613327089158(10)D30875 are also identifiers.

  • Brand
    Stryker
  • Product
    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number and lot number on the device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Massachusetts, Michigan, New Jersey, North Carolina, Texas, Washington.

Recall timeline

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

1. Firm started the recall: Nov 21, 201912. FDA classified it Class II: Jan 7, 202023. Published in FDA’s Enforcement Report: Jan 15, 202034. FDA terminated the recall: Nov 13, 2020420192020
  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-0781-2020 (November 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0781-2020 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