Recall Z-2134-2012 ยท GXI Probe, Radiofrequency Lesion
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Aug 2, 2012 (initiated Jul 17, 2012) |
| Status | Terminated |
| 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 |
| Root cause | 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 (Reca |
| Quantity | 210 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032406 | STRYKER RF ELECTRODES AND CANNULAE Stryker Instruments, Apr 1, 2004 |