Events

Recall of Device Recall Zimmer Anatomical Shoulder Handle for Rasp

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

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
    70993
  • Event Risk Class
    Class 2
  • Event Number
    Z-1523-2015
  • Event Initiated Date
    2015-03-18
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135821
  • 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 manual surgical instrument - Product Code LXH
  • Reason
    Complaints of difficulties to attach the anatomical shoulder rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). this has the potential for delay in surgery.
  • Action
    On 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. 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. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Device

Device Recall Zimmer Anatomical Shoulder Handle for Rasp
  • Model / Serial
    Lot Number(s):  13870129 &  13878179.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
  • Product Description
    Anatomical Shoulder Handle for Rasp || Item: 01.04233.000 || Used during total joint arthroplasty of the shoulder.
  • Manufacturer
    Zimmer Gmbh

Manufacturer

Zimmer Gmbh
  • Manufacturer Address
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • 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