Recall Z-0915-2011 ยท GXD Generator, Lesion, Radiofrequency
Stryker Instruments Div. of Stryker Corporation
Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. The product is intended for coagulation of soft tissues in orthopedic, spinal and neuorsurgical applications.
| Date | Jan 18, 2011 (initiated Apr 13, 2010) |
| Status | Terminated |
| Reason | This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded section of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this |
| Root cause | Component design/selection |
| Action | Stryker Instruments sent an Urgent - Medical Device Recall Notification letter dated April 13, 2010, to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Stryker notified customers again on May 24, 2010, and again on September 14, 2010, via email, fax, or telephone. Customers were instructed to locate the units and visually inspect each affected cord. Remove the affected cord and dispose of it using their healthcare facilities disposal procedure. If the cord did not show signs of damage, the unit could remain in service until |
| Quantity | 3364 all products |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Portugal, Canada, China, Taiwan, France, Germany, Greece, Spain, India, Italy, Korea, Switzerland, Singapore, and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR Valley Forge Scientific Corp., Apr 1, 2004 |