Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
FDA Recall Z-1323-2015 · Posted 2015-03-26
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Recalling FirmArthroCare Medical Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2015-02-20
Date Terminated2016-02-26
Product Quantity15 units
Reason for Recall
The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).
Firm Action
ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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