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Terminated

RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270

FDA Recall Z-0662-2007 · Posted 2007-03-29

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGXI
Date Initiated2007-01-19
Date Terminated2008-01-18
Product Quantity56 units

Reason for Recall

Product is non-sterile but labeled incorrectly as sterile.

Firm Action

Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K034012SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAESmith & Nephew, Inc. · 2004-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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