Class 2 Device Recall G1 High Speed Electric Handpiece Air Cooled (eG1A)

• Date Initiated by Firm: June 15, 2016
• Create Date: July 21, 2016
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-2253-2016
• Recall Event ID: 74447
• 510(K)Number: K133604
• Product Classification: Motor, drill, electric - Product Code HBC
• Product: Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A); ; Use for cutting and shaping bone including bones of the cranium and spine.
• Code Information: Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Dr; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: 561-494-3673
• Manufacturer Reason for Recall: The graphics at the attachment interface indicating locked and unlocked position are reversed.
• FDA Determined Cause: Employee error
• Action: The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps: " Ensure anyone in your facility impacted by this notification reads this letter carefully. Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating product subject to the recall has been located. Indicate the number of devices found. " The RMA information has been filled in for your convenience. " Please include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by: " Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com " Giving it to your DePuy Synthes Sales Consultant. " This return documentation acknowledges your receipt of medical device removal information. " Return the affected product to your DePuy Synthes Sales Consultant " Keep this notice visibly posted for awareness until all products subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. If you DO NOT HAVE the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFiel
• Quantity in Commerce: 18
• Distribution: Worldwide Distribution: US Distribution to states of: GA and FL; and country of: 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 = HBC and Original Applicant = THE ANSPACH EFFORT, INC.