Class 2 Device Recall 16cm Minimally Invasive Attachment (MIA 16G1)

• Date Initiated by Firm: December 10, 2014
• Date Posted: February 02, 2015
• Recall Status: Terminated on May 09, 2016
• Recall Number: Z-1037-2015
• Recall Event ID: 70184
• 510(K)Number: K133604
• Product Classification: Motor, drill, electric - Product Code HBC
• Product: 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
• Code Information: Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.
• FEI Number: 1045834
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Drive; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: Jennifer Breston; 561-494-3673
• Manufacturer Reason for Recall: Customer complaint indicating the color bands on the MIA16-G1 were not correct.
• FDA Determined Cause: Environmental control
• Action: Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
• Quantity in Commerce: 8
• Distribution: US Distribution to the states of: NC and CA., and Internationally to 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