Recall Z-2134-2012— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-2134-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2012-07-17, terminated 2013-05-02. It names one FDA 510(k) clearance: K032406. 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, spinal, and neurosurgical applications.. 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.

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-07-17
Terminated: 2013-05-02
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K032406 — STRYKER RF ELECTRODES AND CANNULAEStryker Instruments·cleared 2004-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.