Events

Recall of Device Recall COLLARLESS POLISHED TAPER HIP 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-0844-2016
  • 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=143397
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • 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 COLLARLESS POLISHED TAPER HIP PROSTHESIS
  • Model / Serial
    Item numbers: 00-8114-000-00 00-8114-000-10 00-8114-001-00 00-8114-001-10 00-8114-002-00 00-8114-002-10 00-8114-002-18 00-8114-002-30 00-8114-003-00 00-8114-003-10 00-8114-003-18 00-8114-003-30 00-8114-004-00 00-8114-004-10 00-8114-004-20 00-8114-004-23 00-8114-004-26 00-8114-004-30 00-8114-005-00 00-8114-005-10 00-8114-005-30 00-8114-012-18 00-8114-013-18 Lot numbers: 61744462 61744471 61767815 61770620 61774067 61774069 61774070 61774071 61778347 61778352 61779345 61783709 61783710 61783712 61783713 61783715 61783716 61783717 61787012 61787026 61787032 61787033 61787039 61790491 61790493 61790501 61790503 61794997 61794998 61794999 61795001 61795002 61798096 61798097 61801163 61801166 61801167 61801169 61801170 61801172 61801173 61801175 61803852 61803853 61803854 61803855 61803856 61803857 61806780 61806781 61806783 61806784 61806785 61806786 61806795 61809116 61809117 61809118 61809119 61809120 61809121 61812094 61812095 61812096 61812097 61812098 61812101 61812102 61812502 61813926 61813927 61813928 61813929 61813930 61814507 61815827 61815828 61815829 61815830 61815831 61817968 61817970 61817972 61817973 61818534 61818535 61820815 61820816 61822313 61822314 61822317 61824704 61824705 61824706 61824707 61824708 61824709 61824710 61824711 61827848 61827849 61829560 61829562 61829563 61829564 61833280 61833301 61833302 61833303 61833304 61833305 61833306 61833307 61837744 61837745 61840597 61840598 61840599 61840601 61840602 61841627 61841628 61841629 61841630 61841631 61844297 61844298 61846959 61846960 61846961 61846962 61846963 61846964 61846965 61846966 61846967 61846968 61851867 61851868 61851869 61853681 61855217 61855219 61855220 61856107 61856108 61859387 61859950 61860466 61860468 61860469 61862656 61863697 61863702 61863704 61863740 61864107 61864108 61868120 61868121 61868122 61868140 61868141 61868226 61868227 61868228 61868229 61872550 61873644 61873645 61873646 61873647 61873648 61873649 61878460 61878461 61878462 61878463 61878464 61878465 61878466 61881183 61881184 61881185 61881186 61881187 61881188 61882605 61882606 61884446 61884447 61884448 61884449 61884450 61884451 61885889 61885891 61885893 61885894 61885895 61885896 61885897 61886881 61886882 61886883 61886884 61886886 61886888 61886890 61891284 61891285 61891286 61891287 61891350 61895488 61895489 61895490 61896747 61896748 61896750 61896751 61896752 61899081 61899082 61899188 61900816 61901482 61901483 61901484 61901486 61901591 61901592 61901593 61907674 61907675 61907676 61907677 61907678 61907679 61907680 61911438 61911439 61911440 61911441 61914809 61914810 61914812 61914813 61914814 61914815 61914816 61917998 61917999 61918001 61918002 61918003 61921687 61921688 61925024 61926447 61926448 61927037 61928454 61928455 61928456 61928457 61928458 61928459 61928460 61928461 61928462 61928463 61930411 61930412 61930413 61930414 61930415 61930416 61930417 61930418 61930419 61930420 61930446 61932567 61938086 61938087 61942508 61942512 61942515 61942518 61943379 61943380 61943381 61943382 61943383 61943384 61943385 61943618 61945114 61945115 61945116 61945117 61947147 61947698 61947699 61947702 61947709 61947710 61947735 61952548 61952549 61952550 61952551 61952552 61952553 61955182 61955183 61955184 61955185 61955186 61955187 61955188 61955189 61955191 61955193 61955194 61955195 61955608 61955609 61955610 61955611 61957399 61957401 61957402 61957403 61957404 61957405 61957406 61957407 61957408 61957409 61957410 61957411 61957412 61957413 61957414 61957415 61964621 61964622 61964624 61964625 61964626 61964627 61964628 61964629 61964630 61964631 61964634 61964635 61964636 61964637 61964639 61964640 61964641 61969286 61969287 61969288 61969289 61969290 61969291 61977136 61978765 61978767 61978768 61978769 61978770 61978771 61978772 61978773 61981231 61981232 61981236 61981241 61981281 61982549 61982550 61982551 61983692 61983693 61983694 61983695 61983697 61983698 61986788 61986790 61986792 61986793 61986794 61987751 61987752 61987753 61987754 61987755 61987756 61987765 61987766 61987773 61987778 61987782 61987783 61987784 61987785 61987786 61987787 61987788 61987789 61991675 61991676 61991677 61991678 61991679 61991680 61991681 61991682 61991683 61991684 61991685 61993158 61993159 61993161 61993164 61996730 61996731 61996732 61996733 61996734 61996735 61996736 61996737 61996738 61996739 61999588 61999765 61999766 61999775 61999776 61999777 62001327 62001328 62001329 62001330 62001331 62001332 62001333 62001337 62001338 62003971 62003972 62003973 62003974 62003976 62003977 62003978 62003979 62003980 62005396 62006549 62006550 62006551 62006552 62006553 62006554 62006555 62006556 62007731 62007732 62007733 62007734 62007735 62010642 62010643 62010644 62010645 62010646 62010647 62010648 62010649 62010650 62011936 62011937 62014202 62014203 62014204 62014205 62014206 62014207 62014208 62017564 62017565 62017566 62017567 62017568 62017569 62017570 62018466 62018468 62022714 62022715 62022716 62022717 62022718 62024619 62024620 62024622 62028734 62028736 62028739 62028743 62028745 62028748 62030927 62030928 62030929 62030936 62033222 62033223 62033224 62033225 62036884 62036885 62036886 62036887 62036888 62036889 62038366 62042582 62042583 62042584 62042585 62042586 62042587 62046482 62046483 62046484 62050975 62050976 62050977 62050978 62050979 62050980 62055978 62055980 62055985 62060676 62062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  • 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
    CPT 12/14 COCR || prosthesis, hip, semi-constrained, metal/polymer, porous uncemented || various sizes || "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."
  • 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