Z-1886-2017Class II

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

Name: Z-1886-2017 Stryker SmartLife Large Aseptic Housing (7126-120-000)
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2017-02-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-02-28 / Terminated / root cause: sterility

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker SmartLife Large Aseptic Housing (7126-120-000) on 2017-02-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1886-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Posted: 2017-04-27
Terminated: 2023-01-23
Recalling firm: Stryker Corp.
Product: Stryker SmartLife Large Aseptic Housing (7126-120-000)
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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.
Root cause tag: sterility
FDA root cause: 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
Product codes and lots: Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1886-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1886-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-27

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)