Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
FDA Recall Z-0887-06 · Posted 2006-05-31
Recalling FirmRita Medical Systems, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-05-02
Date Terminated2008-02-05
Product Quantity21 units
Reason for Recall
Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
Firm Action
Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
Root Cause
Other
Distribution Pattern
AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
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.