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Recall Observatory FDA recall evidence

Device 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.

Z-0172-2015

October 08, 2014

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 69382
Status
Terminated
Classification
Class II
Quantity
3,138 in total
Official record key
device-enforcement:Z-0172-2015

Official wording

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.

Code information: Part Number 7126-120-000; All lot numbers from 13027 to 14093

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.