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Recall Observatory FDA recall evidence

Device 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, spinal, and neurosurgical applications.

Z-2135-2012

July 17, 2012

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 62504
Status
Terminated
Classification
Class II
Quantity
226
Official record key
device-enforcement:Z-2135-2012

Official wording

Reason: 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

Code information: REF 0406-630-125, lot 1000037535

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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