Class 2 Device Recall SmartTools Knee System

• Date Initiated by Firm: February 20, 2017
• Create Date: April 19, 2017
• Recall Status: Terminated on September 18, 2017
• Recall Number: Z-1868-2017
• Recall Event ID: 76508
• 510(K)Number: K122326
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: SmartTools Knee System; Orthopedic Stereotaxic Instrument
• Code Information: Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711
• Recalling Firm/ Manufacturer: Orthosoft, Inc. dba Zimmer CAS; 75 Queen St #3300; Montreal Canada
• For Additional Information Contact: Customer Service; 574-371-3071
• Manufacturer Reason for Recall: There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
• FDA Determined Cause: Other
• Action: Zimmer Biomet sent an Urgent Medical Device Recall - Lot Removal letter dated February 20, 2017, sent to the affected distributors and hospital Risk Managers and Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: This letter is initiating Phase I of the lot specific field removal of the iASSIST Validation Tool field removal. You are receiving this letter because our records indicate that you have received an affected product that needs to be corrected. Zimmer Biomet is currently making preparations for replacement activities to follow. This document is provided to alert all users of the potential issue and to highlight proper usage of the instrument per the existing surgical techniques in order to minimize the chance of any failure pending a replacement. A separate field removal notification will be issued with detailed instructions in April 2017. You will be notified when a replacement is available. Do not return any product at this time as a part of this field action. Your Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. The affected products can continue to be used until replacements are available. To minimize the chances of bending or breakage during use, please follow the iASSIST Knee Surgical Technique (Ref. 97-9001-101-00 Rev 9) and/or iASSIST Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2), specifically the following warning on pages 36 and 37, respectively. 3. Inspect affected devices before and immediately after use to confirm that the Drive Pins are not bent or broken. In case of breakage, the Drive Pin head will disassemble, as shown below. In the unlikely case of a breakage, make sure that both parts are retrieved from the wound. 4. Please keep Zimmer Biomet
• Quantity in Commerce: 84
• Distribution: Nationwide Distribution
• 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 = OLO and Original Applicant = ZIMMER