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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

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.
Recall Number Z-2134-2012
Classification Class II
Code Info REF 0406-630-115, lot 1000035056
Product Distributed Qty 210
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 to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn.

Event Detail

Event Id 62504
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-17
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.