Reported Jul 18, 2018 · Terminated

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

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?

    • Ankle Arthrodesis Nail
    • right T2 Ankle ¿10x300mm
    • Product Number 18191030S
Lot codes and dates
  • GTIN04546540673398
  • Lot codeK078C7E

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

Why it was recalled

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

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

Notice updated May 21, 2020 · Data as of Sep 19, 6:07 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.