Events

Recall of Provide Protection Caps and Provide Impression Copings

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomet 3i Australia Pty Ltd.

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
    RC-2015-RN-01113-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01113-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has been determined that the provide protection caps (ppc***) and the provide impression copings (pic***) elicit a cytotoxic response (grade 4). the affected products are intended for single, short-term use. the affected products were also distributed within certain provide abutment placement kits (pak****) as well as within certain provide abutment restorative kits (prk***). both the provide protection caps and the provide impression copings are single-use, temporary devices. if the clinician uses either of these products, the patient may experience soft tissue irritation and discomfort.
  • Action
    Customers are to inspect stock and quarantine affected units. Affected units should be returned to the sponsor. The sponsor is to confirm that all affected customers have reviewed the recall notice and return credit to the affected customers. This action has been closed-out on 26/08/2016.

Device

Provide Protection Caps and Provide Impression Copings
  • Model / Serial
    Provide Protection Caps and Provide Impression CopingsProvide Protection CapCatalogueNumber : PPC484, PPC485, PPC654, PPC655All Lots are affectedProvide Impression CopingCatalogueNumber: PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, PIC655HAll Lot Numbersare affectedARTG Number: 120308
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia Pty Ltd
  • 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
    DHTGA