—#154068

Product

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

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017

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.

Root cause (FDA determination)

Use error

Action the firm took

Stryker Instruments issued a written corrective notice via mail including a reminder to follow the IFU cleaning procedures for the Stryker SmartLife Large Aseptic Housings (7126-120-000). A small subset of customers have experienced product issues based on cleaning practices that are causing a deterioration of the housing, and speration of the top and bottom of the housing at the weld. Customers are instructed as follows: Several factors can adversely influence the structural integrity of the device. Below are some suggestions for you to review from the Heavy Duty Care Instructions/Instructions for Use to help reduce undue strain on the housing material: " Stryker recommends following sterilization/autoclaving instructions in the Care Instructions. " Stryker has identified that some customers are applying a pre-treatment to the device, please note that the Care Instructions advise the following that pertain to the application of pretreatments (Reference Page 12 of the Heavy Duty Care Instructions): ALWAYS make sure the detergent solution is completely rinsed from the interior and exterior of the equipment before drying the equipment. ALWAYS prepare the detergent solution according to the manufacturers recommendations. Pay particular attention to the concentration used and the total dispersion. " Stryker recommends when using an auto-washer, assure the appropriate parameters (rinse time/settings) are used as instructed in the Care Instructions (Reference Page 21 of the Heavy Duty Care Instructions). Additionally: Unload the washer-disinfector and visually inspect the equipment for remaining soil or detergent solution. If soil or detergent solution remains, repeat the cleaning procedure using fresh detergent solution. Utilizing cleaning practices outside of the IFU could lead to the housing separating at the weld. The health risk associated with the separation of the housing at the weld, is a potential breach in sterility, which may requ

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Domestic: None Foreign: France, Germany

Timeline

Recall initiated: 2017-02-28
Terminated: 2023-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.