The Recall Desk

FDA (Devices) recall action 69382

Stryker Instruments Div. of Stryker Corporation recalled 2 products on 2014-11-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-11-12
Critical
0
Units
6,276

Why these products were recalled

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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    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 Hand
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Small Aseptic Housing REF 7222-120-000 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 Hand
    Category
    Distribution
    17 states