Events

Rappel de Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Cruciate Retaining CR Flex Mobile Bearing Pre

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 Biomet, Inc..

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
    73142
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0842-2016
  • Date de mise en oeuvre de l'événement
    2016-01-11
  • Date de publication de l'événement
    2016-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143381
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
  • Cause
    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 NexGen Complete Knee Solution MIS Total Knee Procedure Cruciate Retaining CR Flex ...
  • Modèle / numéro de série
    Item numbers: 00-5930-010-01 00-5930-010-02 00-5930-020-01 00-5930-020-02 00-5930-030-01 00-5930-030-02 00-5930-040-01 00-5930-040-02 00-5930-040-41 00-5930-040-42 00-5930-050-01 00-5930-050-02 00-5930-060-01 00-5930-060-02 00-5930-070-01 00-5930-070-02 00-5930-080-01 00-5930-080-02  Lot numbers: 11002165 11002170 11002753 11002755 11004006 11004022 11004039 11004084 11004256 11004347 11004558 11004696 11005020 11005211 11005470 11005509 11005570 11005571 11005811 11006243 11006977 11007624 61785664 61785665 61785666 61785667 61790305 61790857 61795385 61800855 61800872 61803287 61806782 61812454 61812455 61812456 61812463 61812467 61812468 61812471 61818233 61818234 61822441 61822442 61822449 61822451 61822452 61827033 61827040 61827041 61827045 61827085 61827094 61827096 61833079 61833080 61833081 61833102 61833105 61833106 61833108 61833110 61833112 61833116 61833119 61833155 61837978 61837979 61837996 61838014 61842438 61842441 61845754 61849851 61849859 61849879 61854971 61854972 61854979 61854980 61854981 61859585 61859594 61859595 61859609 61859626 61859627 61864921 61864945 61868377 61868390 61868395 61873107 61873122 61873124 61877688 61877689 61877690 61877699 61877701 61877702 61882313 61882314 61882315 61886843 61886845 61886874 61886875 61886876 61886877 61886878 61890992 61890993 61890995 61890996 61890997 61890999 61901917 61901946 61901947 61901948 61901949 61901955 61906759 61906796 61911201 61911202 61911203 61911204 61911221 61916704 61916711 61922810 61922811 61922812 61922821 61922830 61922832 61927192 61927193 61927203 61927205 61927211 61927212 61932746 61943653 61943654 61943655 61943656 61947321 61947322 61947323 61947337 61947338 61947342 61947349 61947350 61953668 61953679 61953680 61953681 61959719 61959720 61959721 61959722 61959724 61959725 61959740 61959745 61959749 61963554 61963558 61963559 61965190 61965203 61965204 61970097 61970098 61970099 61970107 61970108 61970109 61970123 61970124 61970125 61970126 61975239 61975240 61975241 61981904 61981905 61981909 61981912 61981923 61984347 61988672 61988673 61988674 61988675 61988678 61994162 61994163 61994164 61994165 61994166 61994167 61994218 61994222 61994223 61994244 61994245 62001585 62001586 62001610 62001611 62001612 62001613 62001629 62001630 62001653 62001655 62001656 62001665 62008000 62008001 62008002 62008006 62008054 62012904 62012905 62012906 62012907 62012908 62012911 62012912 62012940 62012941 62012945 62019909 62019910 62019911 62019912 62019913 62019919 62019920 62019921 62019922 62019926 62019958 62019959 62026506 62026512 62026513 62026536 62026556 62033463 62033464 62033465 62033466 62033470 62033471 62033526 62033527 62038285 62038286 62038291 62038294 62038295 62038301 62038306 62038317 62045361 62045362 62045363 62045436 62045442 62045444 62052281 62052282 62052315 62057311 62057312 62057313 62057314 62059810 62061683 62061684 62062824 62062825 62062826 62062827 62062828 62062829 62062830 62062831 62062832 62062834 62062835 62062836 62062838 62068711 62068712 62068713 62068714 62068715 62068719 62068720 62068721 62068722 62068723 62068724 62068725 62075405 62075406 62075407 62075408 62075409 62075410 62081249 62081258 62081259 62081260 62087163 62087164 62087165 62087166 62087167 62087168 62087169 62092658 62092686 62092687 62092688 62092689 62092690 62092691 62099395 62099396 62099397 62099398 62099403 62099436 62099437 62099438 62099439 62099440 62106182 62111508 62115253 62115254 62117481 62128965 62128966 62133026 62133027 62133067 62133068 62133069 62133070 62133071 62133072 62133073 62133987 62139065 62139066 62139067 62139069 62139070 62139073 62139074 62139075 62139078 62139080 62139084 62139085 62144780 62144781 62144782 62144783 62144784 62144787 62144788 62144789 62150102 62150103 62150104 62150105 62150106 62150107 62150108 62150109 62150111 62150112 62150113 62156542 62156543 62156544 62156545 62156546 62156547 62156548 62156549 62156550 62156551 62156552 62156553 62156554 62161988 62161989 62161991 62161993 62161994 62161995 62178378 62178379 62178380 62178381 62178382 62178383 62178385 62209211
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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
  • Description du dispositif
    PRCT MIS CR MOB PLT || prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing || various sizes || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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