Events

Rappel de Device Recall Zimmer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer Manufacturing B.V..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72900
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1141-2016
  • Date de mise en oeuvre de l'événement
    2016-01-11
  • Date de publication de l'événement
    2016-03-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143751
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • Action
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • Modèle / numéro de série
    lot no.: 370673 370503 61929690 61929695 370525 370502 61775812 61815339 61836513 370524 62031813 61815340 61986781 62027941 62041736 62296539 370522 37107460 61986656 62031814 62296541 62304916 62337080 370666 371030 61794154 62137460 62142342 62300946 370672 37107637 61988381 62310758 62337085 370521 62019015 62337075 370671 371026 37107402 62255925 62300951 370567 37107452 370670 370527 371028 37107454 62255930 370699 61850299 62009791 62310760 370536 370596 61775816 62025367 62291092 62304917 37107456 61986657 62019062 62271634 62296587 371040 62019072 62255933 370594 61940056 62019117 62272160 370592 371027 37107403 61940058 62031817 62248168 62291094 62300957 370675 371031 37107445 61775814 61836514 62255940 62304919 370535 37107638 62025375 62293097 370678 370677 370676 370600 61621133 370679 37107451 62291097 62025380 370501 61780307 370500 370534 62304921 61929772 37107640 62000545 62255954 62304922 62337065 370560 61794155 62137461 62296599 62337067 371042 62255961 62293095 62293096 370561 62271638 370539 37107446 62291101 370604 37107516 370566 370528 371029 37107458 370569 370700 370680 61788370 37107457 62337060 62337060N 37107455 62255966 370533 62255969 62291088 370701 37107459 62291087 370601 370668 370681 370537 37107493 62322143 37107639 370588 370602 370519 370682 370698 370976 370975 37107526 37107492 61794152 370974 370669 61794153 370674 62041735 62296538 370595 37107557 37107491 370716 370623 370504 37107642 61690442 61809561 61895585 61921810 61925168 61975925 61984350 62271642 62332021 62332022 61779979 61809562 61809564 61817401 61860460 61860461 61860462 61860463 61860465 61860467 61860470 61903221 61903222 61921804 61921811 61938089 61962181 61964829 61975913 61984353 62112704 62112707 62112709 62189929 62189930 62189931 62189932 62323392 62323522 37107542 61641822 61779984 61809563 61819620 61859524 61859526 61859529 61859530 61876091 61876092 61876093 61876094 61876113 61876116 61876117 61903225 61907507 61907508 61907509 61925164 61929679 61929680 61929681 61929682 61964840 61975928 61984359 62101537 62101539 62101540 62101541 62101545 62112717 62112720 62112722 62145215 62145216 62145218 62145220 62145222 62285186 62306312 62306318 62306320 62306321 61984359R 61693764 61779993 61817402 61878963 61878964 61878965 61878966 61895626 61895628 61903223 61903224 61917023 61917024 61938064 61953258 61957019 61962192 61962199 61964849 61984365 62103741 62103742 62103743 62134724 62160912 62160913 62160914 62160915 62160916 62199557 62199559 62306412 62306413 62323688 62333384 62333385 62333386 62333387 61903223R 370722 61722838 61838265 61901052 61901053 61917028 61921805 61967159 61967160 61984366 62199551 62199552 62199553 370639 62291231 62291232 370890 370717 370624 370718 370625 37107499 61779975 61879056 61888729 61982961 62145749 62323145 62323147 370719 37107645 61779980 61779981 61817398 61832886 61859492 61859493 61859494 61859495 61859496 61859497 61859498 61865647 61888732 61953260 61982963 62112712 62137276 62137277 62262836 62262837 62262838 62262839 370732 61857759 61857760 61857761 61857762 61857763 61857764 61857765 61857766 61888733 61893881 61901050 61901051 61925166 61925167 61953262 62008108 62008109 62031773 62103732 62103734 62103737 62103738 62103739 62103740 62189934 62189935 62189936 62306405 62306407 62339509 62339511 62339512 370689 61838260 61879079 61879081 61879083 61879084 61888737 61893882 61907512 61907513 61907514 61917025 61917026 61929683 61929684 62137278 62137279 62160917 62160918 62271651 62271653 62271654 62332019 62332020 61879089 61888739 61917027 61953259 61957033 61962209 61962210 62137280 62137281 62266460 62317433 62317450 370657 61888740 61914133 61964872 61888742 61888743 61914138 370687 371002 37107643 61779976 62137464 62317451 370930 61865644 61865646 61934364 61986666 62114056 62143775 62323529 62345632 370642 37107655 61775809 61859566 61859570 61859571 61859572 61859573 61934365 61934375 62143774 62143777 62143778 62266458 62339506 62339507 62339508 37107644 61832923 61838262 61895627 61907516 61907517 62103744 62139602 62291227 62323745 62345637 370971 61879092 61901054 61920763 61934385 62267796 62267799 370725 61986670 370643 370891 370688 370655 370659 370886 370658 370728 370641 370626 370720 370654 62011700 370729 37107538 370661 370648 370627 370650 37107498 37107533 370723 370651 37107495 370640 371052 371067 61934392 61920782 370628 370629 370563 370631 61898782 61956950 37107496 370630 37107500 37107530 61895595 62137465 370889 37107646 61955491 62323557 370690 370727 61940681 370637 370652 370638 370647 370653 370724 37107502 370632 370633 370634 370635 370944 61817399 61865635 61865639 61865641 61917022 61938070 62101532 62103735 62160925 62319818 62319819 62319820 61779978 61813978 61813979 61819618 61832880 61879060 61879061 61879063 61895599 61907504 61907505 61907506 61938085 61967157 61967158 62034077 62034080 62103730 62103736 62160927 62160928 62271649 62271650 62323149 370721 61779983 61813980 61813981 61832913 61879066 61879068 61879069 61895601 61901044 61901047 61921812 61938101 61938102 61953261 62034088 62034093 62034106 62144815 62144816 62144817 62144818 62160929 62176431 62176437 62291217 62291218 62323605 62323611 37107647 61813985 61813996 61832922 61838255 61879071 61879072 61879073 61895613 61938062 61953257 61956951 61956952 62011698 62011699 62137467 62137469 62160919 62175243 62175247 62176457 62266459 62323656 62335159 62335161 62335163 62335164 370726 61817403 61838263 61867469 61867470 61907518 61907519 61907520 62160920 62160922 62176451 370636 370649 370656 370892
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 43 consists of all product under product code: HSB and same usage: || Item no: || 224001016 M/DN R-F IM NAIL 10MM DIA || 224001018 M/DN R-F IM NAIL 10MM DIA || 224001020 M/DN R-F IM NAIL 10MM DIA || 224001022 M/DN R-F IM NAIL 10MM DIA || 224001024 M/DN R-F IM NAIL 10MM DIA || 224001026 M/DN R-F IM NAIL 10MM DIA || 224001028 M/DN R-F IM NAIL 10MM DIA || 224001030 M/DN R-F IM NAIL 10MM DIA || 224001032 M/DN R-F IM NAIL 10MM DIA || 224001034 M/DN R-F IM NAIL 10MM DIA || 224001036 M/DN R-F IM NAIL 10MM DIA || 224001038 M/DN R-F IM NAIL 10MM DIA || 224001040 M/DN R-F IM NAIL 10MM DIA || 224001042 M/DN R-F IM NAIL 10MM DIA || 224001114 M/DN R-F IM NAIL 11MM DIA || 224001116 M/DN R-F IM NAIL 11MM DIA || 224001118 M/DN R-F IM NAIL 11MM DIA || 224001120 M/DN R-F IM NAIL 11MM DIA || 224001122 M/DN R-F IM NAIL 11MM DIA || 224001124 M/DN R-F IM NAIL 11MM DIA || 224001126 M/DN R-F IM NAIL 11MM DIA || 224001128 M/DN R-F IM NAIL 11MM DIA || 224001130 M/DN R-F IM NAIL 11MM DIA || 224001132 M/DN R-F IM NAIL 11MM DIA || 224001134 M/DN R-F IM NAIL 11MM DIA || 224001136 M/DN R-F IM NAIL 11MM DIA || 224001138 M/DN R-F IM NAIL 11MM DIA || 224001140 M/DN R-F IM NAIL 11MM DIA || 224001142 M/DN R-F IM NAIL 11MM DIA || 224001144 M/DN R-F IM NAIL 11MM DIA || 224001146 M/DN R-F IM NAIL 11MM DIA || 224001218 M/DN R-F IM NAIL 12MM DIA || 224001220 M/DN R-F IM NAIL 12MM DIA || 224001224 M/DN R-F IM NAIL 12MM DIA || 224001226 M/DN R-F IM NAIL 12MM DIA || 224001228 M/DN R-F IM NAIL 12MM DIA || 224001230 M/DN R-F IM NAIL 12MM DIA || 224001232 M/DN R-F IM NAIL 12MM DIA || 224001234 M/DN R-F IM NAIL 12MM DIA || 224001236 M/DN R-F IM NAIL 12MM DIA || 224001238 M/DN R-F IM NAIL 12MM DIA || 224001240 M/DN R-F IM NAIL 12MM DIA || 224001242 M/DN R-F IM NAIL 12MM DIA || 224001244 M/DN R-F IM NAIL 12MM DIA || 224001248 M/DN R-F IM NAIL 12MM DIA || 224001318 M/DN R-F IM NAIL 13MM DIA || 224001324 M/DN R-F IM NAIL 13MM DIA || 224001326 M/DN R-F IM NAIL 13MM DIA || 224001328 M/DN R-F IM NAIL 13MM DIA || 224001330 M/DN R-F IM NAIL 13MM DIA || 224001332 M/DN R-F IM NAIL 13MM DIA || 224001334 M/DN R-F IM NAIL 13MM DIA || 224001336 M/DN R-F IM NAIL 13MM DIA || 224001338 M/DN R-F IM NAIL 13MM DIA || 224001340 M/DN R-F IM NAIL 13MM DIA || 224001344 M/DN R-F IM NAIL 13MM DIA || 224001346 M/DN R-F IM NAIL 13MM DIA || 224001348 M/DN R-F IM NAIL 13MM DIA || 224001422 M/DN R-F IM NAIL 14MM DIA || 224001436 M/DN R-F IM NAIL 14MM DIA || 224001438 M/DN R-F IM NAIL 14MM DIA || 224001440 M/DN R-F IM NAIL 14MM DIA || 224001442 M/DN R-F IM NAIL 14MM DIA || 224001444 M/DN R-F IM NAIL 14MM DIA || 224001446 M/DN R-F IM NAIL 14MM DIA || 224000922 M/DN R-F IM NAIL 9MM DIA || 224000926 M/DN R-F IM NAIL 9MM DIA || 224000928 M/DN R-F IM NAIL 9MM DIA || 224000930 M/DN R-F IM NAIL 9MM DIA || 224000932 M/DN R-F IM NAIL 9MM DIA || 224000934 M/DN R-F IM NAIL 9MM DIA || 224000936 M/DN R-F IM NAIL 9MM DIA || 224000942 M/DN R-F IM NAIL 9MM DIA || 224000946 M/DN R-F IM NAIL 9MM DIA || 225320010 M/DN TIBIAL I/M NAIL 10MM || 225326010 M/DN TIBIAL I/M NAIL 10MM || 225328010 M/DN TIBIAL I/M NAIL 10MM || 225330010 M/DN TIBIAL I/M NAIL 10MM || 225332010 M/DN TIBIAL I/M NAIL 10MM || 225334010 M/DN TIBIAL I/M NAIL 10MM || 225336010 M/DN TIBIAL I/M NAIL 10MM || 225338010 M/DN TIBIAL I/M NAIL 10MM || 225344010 M/DN TIBIAL I/M NAIL 10MM || 225320011 M/DN TIBIAL I/M NAIL 11MM || 225322011 M/DN TIBIAL I/M NAIL 11MM || 225324011 M/DN TIBIAL I/M NAIL 11MM || 225326011 M/DN TIBIAL I/M NAIL 11MM || 225328011 M/DN TIBIAL I/M NAIL 11MM || 225330011 M/DN TIBIAL I/M NAIL 11MM || 225332011 M/DN TIBIAL I/M NAIL 11MM || 225334011 M/DN TIBIAL I/M NAIL 11MM || 225336011 M/DN TIBIAL I/M NAIL 11MM || 225338011 M/DN TIBIAL I/M NAIL 11MM || 225340011 M/DN TIBIAL I/M NAIL 11MM || 225342011 M/DN TIBIAL I/M NAIL 11MM || 225344011 M/DN TIBIAL I/M NAIL 11MM || 225346011 M/DN TIBIAL I/M NAIL 11MM || 225328012 M/DN TIBIAL I/M NAIL 12MM || 225330012 M/DN TIBIAL I/M NAIL 12MM || 225332012 M/DN TIBIAL I/M NAIL 12MM || 225334012 M/DN TIBIAL I/M NAIL 12MM || 225336012 M/DN TIBIAL I/M NAIL 12MM || 225338012 M/DN TIBIAL I/M NAIL 12MM || 225340012 M/DN TIBIAL I/M NAIL 12MM || 225346012 M/DN TIBIAL I/M NAIL 12MM || 225324013 M/DN TIBIAL I/M NAIL 13MM
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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