Radiofrequency Denervation Probes Recalled by Company
Smith & Nephew products were mislabeled as sterile
THURSDAY, March 29 (HealthDay News) -- Smith & Nephew of Andover, Mass., has recalled 539 radiofrequency denervation probes that are mislabeled as sterile when in fact they are non-sterilized. The probes, which are used to treat pain, are used with the Smith & Nephew Electrothermal 20S Spine System.
The company has informed the U.S. Food and Drug Administration of the recall. There have been no reports of adverse effects from using the probes in question, which were distributed domestically and internationally to 134 customers. Customers and distributors have been individually notified of the recall.
The probes are reuseable and should be sterilzed prior to each use. The FDA considers the recall a Class I event, as the "error may result in infections with associated risks including, organ failure and/or death."
The recall affects products with a part number of 7210270 (lots 602549, 602550, 602846, 602847); part number 7210271 (lots 602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999); and part number 7210272 (lots 602543, 602570, 602571, 602850, 603000).