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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker SmartLife Large Aseptic Housing (7126120000)

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  Class 2 Device Recall Stryker SmartLife Large Aseptic Housing (7126120000) see related information
Date Initiated by Firm February 28, 2017
Create Date April 27, 2017
Recall Status1 Terminated 3 on January 23, 2023
Recall Number Z-1886-2017
Recall Event ID 76739
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Stryker SmartLife Large Aseptic Housing (7126-120-000)
Code Information Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
Manufacturer 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.
FDA Determined
Cause 2
Use error
Action 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
Quantity in Commerce 302
Distribution Domestic: None Foreign: France, Germany
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.