PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 3, 2017 Initiated: February 28, 2017 #Z-1886-2017

Product Description

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

Reason for Recall

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.

Details

Units Affected
302
Distribution
Domestic: None Foreign: France, Germany
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
Stryker SmartLife Large Aseptic Housing (7126-120-000). Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 302.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 3, 2017. Severity: Moderate. Recall number: Z-1886-2017.