Reported May 3, 2017 · Terminated

Stryker SmartLife Large Aseptic Housing (7126-120-000)

Stryker Instruments Div. of Stryker Corporation

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

Is this the product you have?

  • Stryker SmartLife Large Aseptic Housing (7126-120-000)
Lot codes and dates
  • Manufacture
  • Start Date for Affected Lots18-Mar-2015
  • Manufacture End Date for Affected Lots31-Jan-2017
Amount recalled
302

Why it was recalled

Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.

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 Jan 23, 2023 · Data as of Sep 19, 6:05 PM UTC

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