Class 2 Device Recall Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery

• Date Initiated by Firm: November 10, 2015
• Date Posted: December 21, 2015
• Recall Status: Terminated on February 19, 2016
• Recall Number: Z-0452-2016
• Recall Event ID: 72688
• Product Classification: Saw, powered, and accessories - Product Code HAB
• Product: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
• Code Information: Model # 01-8507-400-00 & Model # 89-8507-400-00
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
• FDA Determined Cause: Device Design
• Action: Zimmer sent an Urgent Medical Device Correction letter dated November 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review this notification. 2. You will receive copies of notification sent directly to hospital risk managers and surgeons in your territory. As necessary, review and facilitate understanding of this notification by those entities. 3. Further identify hospital risk managers and/or surgeons in your territory who should also receive notification of this update, and supply the information to the entities you have identified. 4. If after reviewing this notification you have further questions or concerns, please call 330-364-0989 between the hours of 8 a.m. and 5 p.m. EST, Monday through Friday. Zimmer instructed their direct customers that they will upgrade the device with the new electronic during their annual preventative maintenance activities. Until the new upgrade is installed, the firm instructed their customers to follow the Instructions for Use.
• Quantity in Commerce: 87
• Distribution: US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.
• 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.