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RF Denerevation Probes for Chronic Back Pain Recalled
ANDOVER, Mass. -- Some radiofrequency (RF) denervation probes distributed from here by Smith & Nephew have been recalled because they were mistakenly labeled as sterile, the company announced.
ANDOVER, Mass., March 30 -- Some radiofrequency (RF) denervation probes distributed from here by Smith & Nephew have been recalled by the manufacturer because they were mistakenly labeled as sterile, the company and the FDA announced this week.
The probes are indicated for exclusive use with the Smith & Nephew Electrotherma 20S Spine System in RF heat lesion procedures for the relief of chronic back 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," the manufacturer said in a press release.
No injuries from the use on non-sterile probes have been reported, the company noted in the release, which was posted on the FDA Web site.
The probes, which were distributed to 134 U.S. and international customers, can be identified by the product number, name, and lot numbers, as reported on the FDA Web site. http://www.fda.gov/oc/po/firmrecalls/smithnephew03_07.html.
