—#110774

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.

FDA product code: GXI — Probe, Radiofrequency Lesion
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K032406
Affected lot / code info: REF 0406-630-125, lot 1000037535

Why it was recalled

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

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.

Timeline

Recall initiated: 2012-07-17
Posted by FDA: 2012-08-02
Terminated: 2013-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.