Z-1886-2017 Class II Terminated
FDA device recall Z-1886-2017 was initiated by Stryker Instruments Div. Of Stryker Corporation on Feb 28, 2017 and is designated Class II. 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… The recall status is terminated (terminated Jan 23, 2023). Affected quantity: 302.
Recall details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- Feb 28, 2017
- Termination Date
- Jan 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 302
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.
Distribution pattern
Domestic: None Foreign: France, Germany
Code information
Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1886-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026