Events

Recall of Device Recall SmartTools Knee System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthosoft, Inc. dba Zimmer CAS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76508
  • Event Risk Class
    Class 2
  • Event Number
    Z-1868-2017
  • Event Initiated Date
    2017-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153399
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    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.
  • 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

Device

Device Recall SmartTools Knee System
  • Model / Serial
    Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SmartTools Knee System || Orthopedic Stereotaxic Instrument
  • Manufacturer
    Orthosoft, Inc. dba Zimmer CAS

Manufacturer

Orthosoft, Inc. dba Zimmer CAS
  • Manufacturer Address
    Orthosoft, Inc. dba Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA