Events

Recall of BlockAid Gloves

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    79082
  • Event Risk Class
    Class 2
  • Event Number
    Z-0609-2018
  • Event Initiated Date
    2017-09-11
  • Event Date Posted
    2018-02-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161304
  • 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
    Accessory, surgical apparel - Product Code LYU
  • Reason
    Cut resistant surgical glove liners lack sterility assurance.
  • Action
    1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Device

BlockAid Gloves
  • Model / Serial
    Item Number Lot Number Expiration Date: 1. 650126 326624 9/30/2017; 2. 650126 330363 11/30/2017; 3. 650128 330363 12/1/2017; 4. 650129 330363 12/1/2017; 5. 650129 351411 6/28/2018; 6. 650127 353495 7/28/2018; 7. 650128 353498 7/28/2018; 8. 650131 353504 7/28/2018; 9. 650129 357204 7/28/2018; 10. 650128 361436 8/28/2018; 11. 650129 361467 8/28/2018; 12. 650128 000011 11/28/2018; 13. 650128 231984 12/22/2018; 14. 650129 000011 2/28/2019; 15. 650128 379203 2/28/2019; 16. 650131 390179 6/28/2019; 17. 650131 395315 8/28/2019; 18. 650128 259231 9/30/2019; 19. 650127 401155 10/28/2019; 20. 650130 402602 10/28/2019; 21. 650127 402602 11/28/2019; 22. 650131 402602 11/28/2019; 23. 650128 393754 12/28/2019; 24. 650129 402602 1/28/2020; 25. 650130 417501 9/28/2020; 26. 650128 437240 11/28/2020; 27. 650127 437240 12/28/2020; 28. 650130 437240 12/28/2020; 29. 650129 437240 1/28/2021; 30. 650128 444717 4/28/2021; 31. 650129 444717 4/28/2021; 32. 650131 457763 4/28/2021; 33. 650128 457130 6/28/2021; 34. 650130 457130 6/28/2021; 35. 650129 457130 8/28/2021; 36. 650130 476615 1/28/2022; 37. 650130 486487 3/28/2022; 38. 650129 486488 3/28/2022; 39. 650130 482368 4/28/2022; 40. 650127 482370 4/28/2022; 41. 650129 482370 4/28/2022; 42. 650130 343401 4/30/2018
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.
  • Product Description
    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer 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