Z-0172-2015 Class II Terminated
FDA device recall Z-0172-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Oct 8, 2014 and is designated Class II. Reason for recall: The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. The recall status is terminated (terminated May 31, 2016). Affected quantity: 3,138 in total.
Recall details
- Product Type
- Devices
- Report Date
- Nov 12, 2014
- Initiation Date
- Oct 8, 2014
- Termination Date
- May 31, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,138 in total
Product description
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
Reason for recall
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Distribution pattern
Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
Code information
Part Number 7126-120-000; All lot numbers from 13027 to 14093
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0172-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026