Z-1886-2017 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

Recall Details

Product Type
Devices
Report Date
May 3, 2017
Initiation Date
February 28, 2017
Termination Date
January 23, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
302

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.

Distribution Pattern

Domestic: None Foreign: France, Germany

Code Information

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