| Class 2 Device Recall Stryker Radiofrequency (RF) cannula | |
Date Initiated by Firm | July 17, 2012 |
Date Posted | August 02, 2012 |
Recall Status1 |
Terminated 3 on May 02, 2013 |
Recall Number | Z-2135-2012 |
Recall Event ID |
62504 |
510(K)Number | K032406 |
Product Classification |
Probe, radiofrequency lesion - Product Code GXI
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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. |
Code Information |
REF 0406-630-125, lot 1000037535 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
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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 | 226 |
Distribution | Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GXI
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