A Medical Device Daily
Smith & Nephew (S&N; London) reported that it is initiating a nationwide recall of 539 RF Denervation Probes.
The Smith & Nephew RF Denervation Probes are indicated for use exclusively with the Smith & Nephew Electrothermal 20S spine system in RF heat lesion procedures for the relief of pain. The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.
Customers who have the product that is being recalled should return it to S&N per the recall instructions.
The company said it voluntarily recalled the products after learning of the labeling error. FDA has been apprised of this action. No injuries have been reported to date associated with this issue, it said.
The product was distributed to 134 domestic and international customers.