Events

Recall of Device Recall Knee Stem Extensions & Impactor Sleeve

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

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
    68818
  • Event Risk Class
    Class 2
  • Event Number
    Z-2552-2014
  • Event Initiated Date
    2014-07-22
  • Event Date Posted
    2014-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129077
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • Action
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Knee Stem Extensions & Impactor Sleeve
  • Model / Serial
    Item Numbers:00598801020, 00598801022, 00598801024, 00598801520, 00598801522, 00598801524, 00598801620, 00598801622, 00598801624, 00598801913, 31810604200, 32598801212, 32598801213, 32598801214, 32598801215, 32598801216, 32598801217, 32598801218, 32598801220, 32598801222, 621519095, 621519115, 621519135, 621519155, 621519175, 621520105, 621520125, 621520145, 621520165, 621520185, 621525105, 621525125, 621525145, 621525165, 681515125, 681515145, 681515165, 681515185, 681515205, 681517125, 681517145, 681517165, 681517185, 681517205, 681517225, 681519105, 681519115, 681519125, 681519135, 681519145, 681519165, 681519185   EXPIRATION DATE PRIOR TO 2024-07
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    Knee Stem Extensions & Impactor Sleeve: || STEM IMPLANT 20MMDX145MM || STEM IMPLANT 22MMDX145MM || STEM IMPLANT 24MMDX145MM || SHARP FLUTED ST 20MMDX75MM || SHARP FLUTED ST 22MMDX75MM || SHARP FLTD ST 24MMDX75MM || SHARP FLUTED ST 20MMDX130MM || SHARP FLUTED ST 22MMDX130MM || SHARP FLUTED ST 24MMDX130MM || CEMENTED STEM EXT 13MM X 145MM || IMPACTOR SLEEVE* || NGK STEM EXT 12X245MM (200MM) || NGK STEM EXT 13X245MM (200MM) || NGK STEM EXT 14X245MM (200MM) || NGK STEM EXT 15X245MM (200MM) || NGK STEM EXT 16X245MM (200MM) || NGK STEM EXT 17X245MM (200MM) || NGK STEM EXT 18X245MM (200MM) || NGK STEM EXT 20X245MM (200MM) || NGK STEM EXT 22X245MM (200MM) || SMOOTH REV STM 9.5MM X 19 || SMOOTH REV STM 11.5MM X 1 || SMOOTH REV STM 13.5MM X 1 || SMOOTH REV STM 15.5MM X 1 || SMOOTH REV STM 17.5MM X 1 || REV FEM STM 10.5MM X 200M || REV FEM STM 12.5MM X 200M || REV FEM STM 14.5MM X 200M || REV FEM STM 16.5MM X 200M || 18.5X200MM REV STEM || REV FEM STM 10.5MM X 250M || REV FEM STM 12.5MM X 250M || REV FEM STM 14.5MM X 250M || REV FEM STM 16.5MM X 250M || 12.5X155MM FLUTED OFFST R || 14.5X155MM FLUTED OFFST R || 16.5X155MM FLUTED OFFST R || 18.5X155MM FLUTED OFFST R || 20.5X155MM FLUTED OFFST R || 12.5X175MM FLUTED REV STM || FLUTE REV STEM - 14.5MM X || FLUTE REV STEM - 16.5MM X || FLUTE REV STEM - 18.5MM X || FLUTE REV STEM - 20.5MM X || FLUTE REV STEM - 22.5MM X || FLUTED REV STM 10.5MM X 1 || FLUTED REV STM 11.5MM X 1 || FLUTED REV STM 12.5MM X 1 || FLUTED REV STM 13.5MM X 1 || FLUTED REV STM 14.5MM X 1 || FLUTED REV STM 16.5MM X 1 || FLUTED REV STM 18.5MM X 1
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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