The Recall Desk

FDA (Devices) recall action 62504

Stryker Instruments Div. of Stryker Corporation recalled 2 products on 2012-08-08

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
2012-08-08
Critical
0
Units
436

Why these products were recalled

Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed

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.

1–2 of 2

  • HighFDA (Devices)··2012-08-08

    Stryker Recalls 210 RF Cannula Units Due to Packaging Error

    Stryker is recalling 210 RF Cannula units because 5mm and 10mm needles were mistakenly packaged in the wrong boxes. This error could lead to thermal skin lesions if the larger tip is used in cervical procedures.

    Product
    RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-08

    Stryker Recalls RF Cannulas Due to Packaging Error

    Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.

    Product
    RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic…
    Category
    Distribution
    0 states