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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Radiofrequency (RF) cannula

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  Class 2 Device Recall Stryker Radiofrequency (RF) cannula see related information
Date Initiated by Firm July 17, 2012
Date Posted August 02, 2012
Recall Status1 Terminated 3 on May 02, 2013
Recall Number Z-2134-2012
Recall Event ID 62504
510(K)Number K032406  
Product Classification Probe, radiofrequency lesion - Product Code GXI
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.
Code Information REF 0406-630-115, lot 1000035056
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
269-323-7700
Manufacturer 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
FDA Determined
Cause 2		 Labeling mix-ups
Action Stryker sent an Urgent MEDICAL DEVICE Recall Notifications dated July 16, 2012 to all consignees. The letter identified the affected products, problem and actions to be taken. Customers/distributors were instructed to check their inventory and quarantine any affected product found, complete and fax the business reply form to Stryker Instruments Regulatory Department, 866-521-2762 and return all affected product using the pre-paid shipper provided. Upon receipt of the recalled product, a replacement will be issued. For questions regarding this recall please contact Stryker Instruments (Recall Coordinator) Monday-Friday 8am-5pm (EST) at 269-389-4354.
Quantity in Commerce 210
Distribution Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = STRYKER INSTRUMENTS
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