Recall Z-0172-2015— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2014-10-08, terminated 2016-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-08
- Terminated
- 2016-05-31
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.