• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Smith & Nephew Issues Nationwide Recall of RF Denervation Probes Used for the Spine

 

Contact:
Joe Metzger
978-749-1330

 

FOR IMMEDIATE RELEASE -- Andover, MA -- March 26, 2007 -- Smith & Nephew Inc. is initiating a nationwide recall of 539 RF Denervation probes for the part numbers and models listed in the table below.

The Smith & Nephew RF Denervation probes are indicated for use exclusively with the Smith & Nephew ELECTROTHERMAL(TM) 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 product that is being recalled should return it to Smith & Nephew per the recall instructions. The recall includes the following products and lot numbers:

Part #

Description

Lot numbers

7210270RF Denervation Probe602549, 602550, 602846, 602847
7210271RF Denervation Probe602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999
7210272RF Denervation Probe602543, 602570, 602571, 602850, 603000

The company 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.

Product was distributed to 134 domestic and international customers. It can be identified by the product number, name, and lot numbers identified above. Smith & Nephew has notified its distributors and customers and is arranging for return and replacement of all recalled products.

Consumers with questions may contact the company at 1-800-343-5717. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/Safety/MedWatch/DownloadForms/default.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

####

RSS Feed for FDA Recalls Information [what's this?]