Class 2 Device Recall MicroSpeed Uni Motor System

• Date Initiated by Firm: November 22, 2010
• Date Posted: March 02, 2011
• Recall Status: Terminated on July 05, 2012
• Recall Number: Z-1474-2011
• Recall Event ID: 57419
• 510(K)Number: K053526
• Product Classification: Motor, drill, electric - Product Code HBC
• Product: Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surgery.
• Code Information: Part #GD670 - all distributed lot numbers and serial numbers
• FEI Number: 2916714
• Recalling Firm/ Manufacturer: Aesculap Inc; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Bill Moukoulis; 800-258-1946 Ext. 5254
• Manufacturer Reason for Recall: Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.
• FDA Determined Cause: Software design
• Action: AESCULAP sent an IMPORTANT CORRECTION NOTICE letter dated November 22, 2010, to all affected consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to not use the motors for thread cutting and removal of screws. If any unusual reactions of any cutting tools were observed consignees should check to ensure that the motor is not running in the opposite direction. If any error message is displayed, consigness were instructed to not use the motor. Consignees were also instructed to check both directions of running before use and do not use a motor which produces an error message in one direction. Aesculap would be providing all customers with a software update to the MicroSpeed Uni control box either by the unit being returned to Aesculap for update or by firm representative doing the upgrade on site at their facility. For questions regarding this recall call 800-258-1946 x5254 or 800-258-1946 x5267.
• Quantity in Commerce: 91 units
• Distribution: Worldwide Distribution - USA including CA, CO, DE, FL, GA, IN, LA, MO, NC, NJ, OK, PA, TN, TX, and VA and the country of 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 = HBC