Recall Z-1886-2017 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Stryker Instruments Div. of Stryker Corporation
Stryker SmartLife Large Aseptic Housing (7126-120-000)
| Date | Feb 28, 2017 |
| Status | Terminated |
| Reason | 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 | 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/Instruc |
| Quantity | 302 |
| Distribution | Domestic: None Foreign: France, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.