Reported Jun 18, 2025 · Ongoing

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Stryker GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker GmbH · Bohnackerweg 1 · Selzach · N/A

Is this the product you have?

    • Long Nail
    • RIGHT Gamma4 10x320mm x 125
    • component of the Gamma4 System
  • Catalog Number84250320S
Lot codes and dates
  • Catalog Number84250320S
  • GTIN07613327479515
  • Lot NumberK1BC9B7

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.