Stryker Instruments Div. of Stryker Corporation recalls Stryker SmartLife Large Aseptic Housing (7126-120-000)

Recall date

February 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1886-2017

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Domestic: None Foreign: France, Germany

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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