Reported Nov 23, 2016 · Terminated

RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

Stryker Instruments Div. of Stryker Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Is this the product you have?

  • RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Lot codes and dates
  • RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U
Amount recalled
2,675

Where it was sold

Why it was recalled

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 25, 2017 · Data as of Sep 19, 5:22 PM UTC

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