The Recall Desk

FDA (Devices) recall action 65456

Stryker Instruments Div. of Stryker Corporation recalled 3 products on 2013-07-24

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-07-24
Critical
0
Units
20

Why these products were recalled

The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100

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

1–3 of 3

  • HighFDA (Devices)··2013-07-24

    Stryker TPS Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.

    Product
    Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic…
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2013-07-24

    Stryker CORE Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.

    Product
    CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues…
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2013-07-24

    Stryker RemB Electric Universal Driver Recalled for Unintended Activation

    Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.

    Product
    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric…
    Category
    Distribution
    8 states