Events

Recall of Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS

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
    73142
  • Event Risk Class
    Class 2
  • Event Number
    Z-0837-2016
  • Event Initiated Date
    2016-01-11
  • Event Date Posted
    2016-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143340
  • 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, patello/femoral, semi-constrained, cemented, metal/polymer - Product Code KRR
  • Reason
    Ldpe bag containing the implant adheres to the highly polished implant surface.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.

Device

Device Recall ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
  • Model / Serial
    Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-014-01 00-5926-014-02 00-5926-015-01 00-5926-015-02  Lot numbers: 11003385 11003487 11003827 11003957 11004055 11004100 11004102 11004106 11004145 11004378 11004444 11004449 11004454 11004464 11004499 11005712 11005779 11005783 11006058 11006623 11006851 11006878 11006925 11006973 11008245 11008259 11008270 11008331 11008381 61771793 61771795 61777453 61777454 61777455 61777456 61777457 61782636 61782637 61782638 61782639 61782640 61782641 61782642 61788821 61788822 61788823 61788824 61788825 61788826 61788827 61795693 61795694 61795695 61795696 61795697 61795698 61801039 61801040 61801041 61801042 61801043 61801044 61805590 61805591 61805592 61805593 61805594 61805595 61809895 61809897 61809898 61809899 61809901 61809902 61815366 61815367 61815368 61815369 61815370 61815371 61822252 61822253 61822254 61822255 61822256 61822257 61822258 61822259 61824055 61824056 61824057 61824058 61824059 61824060 61824061 61830909 61830910 61830911 61830912 61830913 61830914 61830915 61836415 61836416 61836417 61836418 61836419 61836420 61846210 61846211 61846212 61846213 61846214 61846215 61846216 61848468 61848469 61848470 61848471 61848472 61848473 61848474 61853892 61853893 61853896 61853897 61853898 61853899 61853901 61857280 61857281 61857282 61857283 61857284 61857286 61857287 61861620 61861621 61861622 61861623 61861624 61861625 61861626 61866469 61866470 61866471 61866472 61866473 61866474 61866475 61871356 61871357 61871358 61871359 61871360 61871361 61871362 61871854 61871855 61871856 61871857 61871858 61871859 61871860 61876121 61876122 61876123 61876124 61876125 61885074 61885075 61885076 61885077 61885078 61885079 61889296 61889297 61889298 61889301 61889302 61889303 61894348 61894349 61894350 61894351 61894352 61894353 61899464 61899465 61899466 61899467 61899468 61899469 61904075 61904076 61904077 61904078 61904079 61904080 61910479 61910480 61910481 61910482 61910483 61910484 61915945 61915946 61915947 61915948 61921254 61921255 61921256 61921257 61928583 61928584 61928585 61928586 61992014 61992015 61992016 61992017 61992018 61992019 61992020 61992021 61992022 61992023 61992024 61992025 61992026 61992027 61992028 61992029 61992568 61992569 61992570 61992571 61992572 61992573 61992574 61992575 61992576 61992577 61992578 61992579 61992580 61992581 61992582 61992583 61992584 61992585 61992586 61992587 61992588 61992589 61992590 61992591 61993455 61993456 61993457 61993458 61993459 61993460 61993461 61993462 61993463 61993464 61993465 61993466 61993467 61993468 61993469 61999989 61999990 61999991 61999992 61999993 61999994 62005581 62005582 62005583 62005584 62005585 62005586 62005587 62013282 62013283 62013284 62013285 62013286 62013287 62013288 62013289 62020246 62020247 62020248 62020249 62020250 62020251 62020252 62020253 62025553 62025554 62025555 62025556 62025557 62025558 62025559 62025560 62032468 62032469 62032470 62032471 62032472 62032473 62032474 62032475 62038515 62038516 62038517 62038518 62038519 62038520 62038521 62045659 62045660 62045661 62045662 62045663 62045664 62054510 62054511 62054512 62054513 62054514 62054515 62054516 62056479 62056480 62056481 62056482 62056483 62056484 62056485 62056486 62056487 62062023 62062024 62062025 62062026 62062027 62062028 62062029 62062030 62068076 62068077 62068078 62068079 62068080 62074799 62074801 62074802 62074803 62074804 62074805 62080616 62080617 62080618 62080619 62080620 62080621 62080622 62086834 62086835 62086836 62086837 62086838 62086839 62092322 62092323 62092324 62092325 62098933 62104089 62104090 62104091 62104847 62105354 62110639 62110641 62110642 62110643 62110644 62132368 62132369 62132370 62139198 62139199 62139201 62139202 62144831 62144832 62144833 62144834 62150439 62150440 62150441 62150442 62150443 62160003 62160644 62160645 62160646 62160647 62160648 62160649 62160650 62160795 62160796 62160797 62164352 62164353 62164354 62164355 62164356 62165048 62165049 62165050 62165051 62165052 62165053 62170563 62170564 62170565 62170566 62172846 62172847 62172848 62172849 62172850 62176085 62176086 62176087 62176088 62176089 62176090 62181332 62181333 62181334 62181335 62181336 62181337 62181338 62183111 62183113 62183115 62183116 62183118 62199347 62199348 62199932 62199933 62199934 62199936 62199937 62199938 62199939 62205119 62205121 62205122 62205123 62205124 62205125 62205126 62209829 62209830 62209832 62209833 62209834 62209835 62209837 62217947 62217948 62217950 62217951 62217952 62217953 62217954 62223899 62223900 62223901 62223902 62223903 62223904 62231264 62231265 62231266 62231267 62231268 62231269 62231270 62231271 62238158 62238159 62238160 62238161 62238162 62238163 62238164 62238165 62238166 62240167 62245934 62245936 62255544 62255546 62255547 62255548 77001685 77001686 77001687 77001688 77001689 77001690 77001691 77001692 77001693 77001694 77001695 77001696 77001697 77001698
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
  • Product Description
    Gender PFJ FEMORAL COMP, || prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer || various sizes || " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
  • 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