Class 2 Device Recall G1 Dissection Tool

• Date Initiated by Firm: August 26, 2016
• Create Date: September 16, 2016
• Recall Status: Terminated on November 29, 2017
• Recall Number: Z-2838-2016
• Recall Event ID: 75121
• 510(K)Number: K113476
• Product Classification: Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
• Product: G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Code Information: Material M-3DC-2-G1 Batch J313108568 & J316017637
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Dr; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: Jennifer Breston; 561-627-1080
• Manufacturer Reason for Recall: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
• FDA Determined Cause: Device Design
• Action: On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall. ACTION REQUIRED Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach Effort, Inc. asks that you: 1) There is no requirement for retaining your inventory of Gl Dissection Tools. 2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended. The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be used. 3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details provided on the form. Returning the form promptly will prevent you from receiving repeat notices. 1. Share this letter with others in your facility that needs to be made aware of this recall (correction). 2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward this letter as appropriate immediately. 3. Keep a copy of this notice with the product(s) subject to the recall (correction). If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
• Quantity in Commerce: 88
• Distribution: AZ, DC, CA, MD, MI, and OR Switzerland
• 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 = HBE and Original Applicant = THE ANSPACH EFFORT, INC.