Events

Recall of Device Recall Trauma Tubes and Plates

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-2550-2014
  • 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=129074
  • 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
    Plate, fixation, bone - Product Code HRS
  • 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 Trauma Tubes and Plates
  • Model / Serial
    Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514      EXPIRATION DATE PRIOR TO 2024-07
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    Trauma Tubes and Plates: || TUBE & SCP PLT 90DX150LG || TUBE & SCP PLT 90DX205LG || TUBE & SCP PLT 90DX255LG || TUBE & SCP PLT 95DX150LG || TUBE & SCP PLT 95DX205LG || TUBE & SCP PLT 95DX255LG || TUBE&SCP; PLT 130DX8H || TUBE&SCP; PLT 130DX10H || TUBE&SCP; PLT 130DX12H || TUBE&SCP; PLT 130DX14H || TUBE&SCP; PLT 135DX8H || TUBE&SCP; PLT 135DX10H || TUBE&SCP; PLT 135DX12H || TUBE&SCP; PLT 135DX14H || TUBE&SCP; PLT 140DX8H || TUBE&SCP; PLT 140DX10H || TUBE&SCP; PLT 140DX12H || TUBE&SCP; PLT 140DX14H || TUBE&SCP; PLT 145DX8H || TUBE&SCP; PLT 145DX10H || TUBE&SCP; PLT 145DX12H || TUBE&SCP; PLT 145DX14H || TUBE&SCP; PLT 150DX6H || TUBE&SCP; PLT 150DX8H || TUBE&SCP; PLT 150DX10H || TUBE&SCP; PLT 150DX12H || TUBE&SCP; PLT 150DX14H || VERSA-FX II SC TUBE PLT 90DX6H || VERSA-FX II SC TUBE PLT 90DX8H || VERSA-FXII SC TUBE PLT 90DX10H || VERSA-FXII SC TUBE PLT 90DX12H || VERSA-FXII SC TUBE PLT 90DX14H || VERSA-FXII SC TUBE PLT 95DX6H || VERSA-FXII SC TUBE PLT 95DX8H || VERSA-FXII SC TUBE PLT 95DX10H || VERSA-FXII SC TUBE PLT 95DX12H || VERSA-FXII SC TUBE PLT 95DX14H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE || VERSA-FX II STD TUBE 130DX8H || VERSA-FX II STD TUBE 130DX10H || VERSA-FX II STD TUBE 130DX12H || VERSA-FX II STD TUBE 130DX14H || VERSA-FX II STD TUBE 135DX8H || VERSA-FX II STD TUBE 135DX10H || VERSA-FX II STD TUBE 135DX12H || VERSA-FX II STD TUBE 135DX14H || VERSA-FX II STD TUBE 140DX8H || VERSA-FX II STD TUBE 140DX10H || VERSA-FX II STD TUBE 140DX12H || VERSA-FX II STD TUBE 140DX14H || VERSA-FX II STD TUBE 145DX8H || VERSA-FX II STD TUBE 145DX10H || VERSA-FX II STD TUBE 145DX12H || VERSA-FX II STD TUBE 145DX14H || VERSA-FX II STD TUBE 150DX8H || VERSA-FX II STD TUBE 150DX10H || VERSA-FX II STD TUBE 150DX12H || VERSA-FX II STD TUBE 150DX14H || VERSA-FX II KEYLESS TB 130DX8H || VERSA-FX II KEYLESS TB 135DX8H || VERSA-FX II KEYLESS TB 140DX8H || VERSA-FX II KEYLESS TB 145DX8H || VERSA-FX II KEYLESS TB 150DX8H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE
  • 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