Recall Z-1886-2017— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-02-28, terminated 2023-01-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker SmartLife Large Aseptic Housing (7126-120-000). 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-28
- Terminated
- 2023-01-23
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.