Class 2 Device Recall Zimmer Periarticular Locking Plate System

• Date Initiated by Firm: June 10, 2014
• Date Posted: July 30, 2014
• Recall Status: Terminated on January 09, 2015
• Recall Number: Z-2131-2014
• Recall Event ID: 68657
• 510(K)Number: K040593
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
• Code Information: Part Number 00-2358-014-04; lot 62276042
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
• FDA Determined Cause: Device Design
• Action: Zimmer sent an Urgent Medical Device Recall letter dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They instructed their distributors to do the following: 1. Please locate, quarantine, and return the affected product (part number 00-2358-014-04; lot 62276042) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager and Surgeon letter directly. Additionally, Risk Managers and Surgeon that were identified via invoice data will also receive a letter directly. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7.If after reviewing this notification you have questions or concerns, please call 1-877-946-2761. They instructed the Surgeons and Risk Managers to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Inspect inventory for part number 00-2358-014-04; lot number 62276042. Quarantine the device and contact your Zimmer sales representative to remove and return the affected device. 3. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.
• Quantity in Commerce: 28 units
• Distribution: Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
• 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 = HRS and Original Applicant = ZIMMER, INC.