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Recall Observatory FDA recall evidence

Device product

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

Z-1886-2017

February 28, 2017

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 76739
Status
Terminated
Classification
Class II
Quantity
302
Official record key
device-enforcement:Z-1886-2017

Official wording

Reason: 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.

Code information: Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017

Distribution pattern: Domestic: None Foreign: France, Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.