Wednesday, March 28, 2007

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

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 #
Lot numbers
RF Denervation Probe
602549, 602550, 602846, 602847
RF Denervation Probe
602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999
RF Denervation Probe
602543, 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.

Regular Mail: use postage-paid FDA form 3500 available at: Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

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