Class 3 Device Recall Access Surgical International

• Date Initiated by Firm: December 02, 2005
• Date Posted: January 24, 2006
• Recall Status: Terminated on June 14, 2006
• Recall Number: Z-0434-06
• Recall Event ID: 34236
• 510(K)Number: K943958
• Product Classification: Gastroscope, General & Plastic Surgery - Product Code GCK
• Product: Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile , Reusable Stainless Steel Surgical Instrument Part Number: 125382A
• Code Information: Lot Number: 305
• Recalling Firm/ Manufacturer: Tnco, Inc.; 15 Colebrook BLVD.; P.O. Box 231; Whitman MA 02382-0231
• For Additional Information Contact: Kenneth V. Campanale; 781-447-6661 Ext. 7536
• Manufacturer Reason for Recall: The tip may not engage with the handle and may dislodge
• FDA Determined Cause: Process control
• Action: TNCO notified customers by telephone and certified letter on 01/2/06. Accounts are requested to return inventory.
• Quantity in Commerce: 185 units
• Distribution: CA, CT, DC, IL, IN, FL. GA, NC, NY, UT Canada
• 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 = GCK