Events

Recall of Device Recall GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM

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
    78706
  • Event Risk Class
    Class 2
  • Event Number
    Z-1060-2018
  • Event Initiated Date
    2017-11-29
  • 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=162419
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The ldpe bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the ldpe bag on the implant after it is removed from the bag.
  • Action
    A similar recall was initiated in January 2016 to remove remaining inventory packaged in the old bag. Further evaluation identified additional lots packaged in the old bag that were not included in the January 2016 recall; therefore, resulting in this new recall for the additional lots packaged in the old bag. A firm, Zimmer Biomet, sent an "Urgent Medical Device Recall" notices dated November 29, 2017 and response forms to customers. The notice described the product, problem and actions to be taken. The Customers should take the following action: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additi

Device

Device Recall GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM
  • Model / Serial
    00-5414-013-02 61768287 00-5414-013-02 61768287R 00-5414-013-02 77001023 00-5414-013-02 61871391 00-5414-013-02 61876203 00-5414-013-02 61889334 00-5414-013-02 61910523 00-5414-013-02 61940029 00-5414-013-02 61971424 00-5414-013-02 61983528 00-5414-013-02 61994980 00-5414-013-02 62001882 00-5414-013-02 62020365 00-5414-013-02 62032695 00-5414-013-02 11006436 00-5414-013-02 62046201 00-5414-013-02 62054637 00-5414-013-02 62054637R 00-5414-013-02 62074928 00-5414-013-02 62094873 00-5414-013-02 62103499 00-5414-013-02 62117187 00-5414-013-02 62128275 00-5414-017-01 61777741 00-5414-017-01 61801560 00-5414-017-01 77001027 00-5414-017-01 61837057 00-5414-017-01 61867209 00-5414-017-01 61885276 00-5414-017-01 61889362 00-5414-017-01 61872013 00-5414-017-01 61904178 00-5414-017-01 61904178R 00-5414-017-01 61910561 00-5414-017-01 11004925 00-5414-017-01 61928674 00-5414-017-01 61952632 00-5414-017-01 61963823 00-5414-017-01 61971475 00-5414-017-01 61988083 00-5414-017-01 61994991 00-5414-017-01 62005770 00-5414-017-01 77001464 00-5414-017-01 62025843 00-5414-017-01 62041147 00-5414-017-01 62054638 00-5414-017-01 11006490 00-5414-017-01 62062144 00-5414-017-01 62074934 00-5414-017-01 62094875 00-5414-017-01 62117197 00-5414-017-02 61774297 00-5414-017-02 61824684 00-5414-017-02 61871418 00-5414-017-02 61876224 00-5414-017-02 61889363 00-5414-017-02 61899535 00-5414-017-02 61904179 00-5414-017-02 61933394 00-5414-017-02 61950165 00-5414-017-02 61928675 00-5414-017-02 61950166 00-5414-017-02 61952633 00-5414-017-02 61950164 00-5414-017-02 11005236 00-5414-017-02 11005311 00-5414-017-02 61958472 00-5414-017-02 61994989 00-5414-017-02 62001895 00-5414-017-02 62005771 00-5414-017-02 62025844 00-5414-017-02 62054634 00-5414-017-02 62046213 00-5414-017-02 62062145 00-5414-017-02 62074937 00-5414-017-02 11006896 00-5414-017-02 62104630 00-5414-017-02 62110727
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ || N-K FLX GSF NP FEM SZ 0 RT || N-K FLX GSF NP FEM SZ 4 LT || N-K FLX GSF NP FEM SZ 4 RT || Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, 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