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Terminated

Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.

FDA Recall Z-0452-2008 · Posted 2007-12-11

Recalling FirmConMed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-11-02
Date Terminated2010-03-31
Product Quantity11,319 cases (476,160 units)

Reason for Recall

Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

Firm Action

Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.

Root Cause

Process design

Distribution Pattern

Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991855CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXXConmedcorp · 1999-06-15K935091ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODEConmedcorp · 1994-02-28

Official Source

View FDA Recall →

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

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