Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2012 - (Recall #: Z-2134-2012)
See the recall detail below. You can also see other recalls from the same firm in 2012.
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, spinal, and neurosurgical applications.
Class II
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
REF 0406-630-115, lot 1000035056
Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.
Voluntary: Firm initiated