Events

Recall of Device Recall PTHYBRID

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, 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
    63850
  • Event Risk Class
    Class 2
  • Event Number
    Z-0660-2013
  • Event Initiated Date
    2012-12-06
  • Event Date Posted
    2013-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114932
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Biomet is recalling part number pt-113950 pt hybrid glenoid post, following an investigation which identified that the male thread of the post may be oversized. this oversized condition can vary in degree and may lead to the following three events: 1) if the pt hybrid glenoid post is not fully seated into the hybrid base and the implant construct is implanted, then a gap of 1-3 mm will be prese.
  • Action
    Biomet Inc. sent a Urgent Medical Device Recall Notices dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notice identified the reason for the recall including directions to immediately locate, discontinue use of the device. Surgeons were asked to continue monitoring of patients implanted. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with product to be returned are asked to obtain RGA # by calling 574-372-6677 . A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 574-371-1570, Monday- Friday 8 a.m. to 5 p.m.

Device

Device Recall PTHYBRID
  • Model / Serial
    Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
  • Product Description
    PT113950 PT HYBRID Glenoid Post || Regenerex porous titanium construct || Sterile R || Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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