Class 2 Device Recall Fixed Tip Electrosurgical Electrode.

• Date Initiated by Firm: June 11, 2004
• Date Posted: September 22, 2004
• Recall Status: Terminated on November 09, 2004
• Recall Number: Z-1074-04
• Recall Event ID: 29430
• 510(K)Number: K912780
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
• Code Information: Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
• Recalling Firm/ Manufacturer: Encision, Inc.; 4828 Sterling Dr; Boulder CO 80301-2350
• For Additional Information Contact: Ms. Judith V. King; 303-444-2600 Ext. 117
• Manufacturer Reason for Recall: Electrosurgical tip may break or come off during use.
• FDA Determined Cause: Other
• Action: Customers were notified beginning 6/15/2004 by phone or visit.
• Quantity in Commerce: 335 units
• Distribution: AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI