FDAFDA · Alimentos y medicamentos·N.º oficial Z-0835-2016
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer 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 and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."
Publicado el 2 de marzo de 2016 · Inicio del retiro: 11 de enero de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
LDPE bag containing the implant adheres to the highly polished implant surface.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer Biomet, Inc.
- Distribuidor
- 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
- Lote
- Item numbers: 00-5966-013-01 00-5966-013-02 00-5966-014-01 00-5966-014-02 00-5966-015-01 00-5966-015-02 00-5966-016-01 00-5966-016-02 00-5966-017-01 00-5966-017-02 00-5970-011-01 00-5970-011-02 00-5970-012-01 00-5970-012-02 00-5970-013-01 00-5970-013-02 00-5970-013-03 00-5970-013-04 00-5970-014-01 00-5970-014-02 00-5970-014-03 00-5970-014-04 00-5970-015-01 00-5970-015-02 00-5970-015-03 00-5970-015-04 00-5970-016-01 00-5970-016-02 00-5970-017-01 00-5970-017-02 00-5970-018-01 00-5970-018-02 00-5972-011-01 00-5972-011-02 00-5972-012-01 00-5972-012-02 00-5972-013-01 00-5972-013-02 00-5972-013-03 00-5972-013-04 00-5972-014-01 00-5972-014-02 00-5972-014-03 00-5972-014-04 00-5972-015-01 00-5972-015-02 00-5972-015-03 00-5972-015-04 00-5972-016-01 00-5972-016-02 00-5972-017-01 00-5972-017-02 00-5972-018-01 00-5972-018-02 00-5990-011-01 00-5990-011-02 00-5990-011-31 00-5990-011-32 00-5990-012-01 00-5990-012-02 00-5990-012-31 00-5990-012-32 00-5990-013-01 00-5990-013-02 00-5990-013-31 00-5990-013-32 00-5990-014-01 00-5990-014-02 00-5990-014-31 00-5990-014-32 00-5990-015-01 00-5990-015-02 00-5990-015-31 00-5990-015-32 00-5990-016-01 00-5990-016-02 00-5990-016-31 00-5990-016-32 00-5990-017-01 00-5990-017-02 00-5990-017-31 00-5990-017-32 00-5990-017-91 00-5990-017-92 00-5990-018-01 00-5990-018-02 00-5990-018-31 00-5990-018-32 00-5992-012-01 00-5992-012-02 00-5992-012-31 00-5992-012-32 00-5992-013-01 00-5992-013-02 00-5992-013-31 00-5992-013-32 00-5992-014-01 00-5992-014-02 00-5992-014-31 00-5992-014-32 00-5992-015-01 00-5992-015-02 00-5992-015-31 00-5992-015-32 00-5992-016-01 00-5992-016-02 00-5992-016-31 00-5992-016-32 00-5992-017-01 00-5992-017-02 00-5992-017-31 00-5992-017-32 00-5992-018-01 00-5992-018-02 00-5992-018-31 00-5992-018-32 Lot numbers: 11002771 11003380 11003415 11003450 11003451 11003469 11003477 11003574 11003575 11003576 11003583 11003586 11003593 11003597 11003601 11003602 11003612 11003613 11003626 11003643 11003644 11003666 11003673 11003825 11003832 11003870 11003871 11003889 11003890 11003893 11003941 11003942 11003954 11003956 11004035 11004043 11004058 11004080 11004101 11004189 11004302 11004500 11004508 11004543 11004566 11004597 11004683 11004766 11004806 11004817 11004868 11004869 11004870 11004894 11004914 11004946 11004950 11004952 11004954 11004955 11004957 11004958 11004959 11004971 11004972 11004980 11005018 11005034 11005054 11005055 11005057 11005068 11005096 11005099 11005100 11005112 11005232 11005233 11005248 11005320 11005328 11005367 11005374 11005425 11005444 11005461 11005489 11005491 11005511 11005530 11005561 11005594 11005602 11005629 11005632 11005647 11005674 11005677 11005678 11005685 11005697 11005703 11005707 11005732 11005747 11005752 11005764 11005795 11005796 11005820 11005891 11005893 11005911 11005912 11005922 11005966 11006019 11006035 11006055 11006059 11006084 11006113 11006116 11006160 11006194 11006202 11006245 11006248 11006249 11006262 11006316 11006319 11006332 11006362 11006365 11006403 11006458 11006471 11006538 11006588 11006598 11006600 11006604 11006605 11006607 11006631 11006640 11006670 11006695 11006718 11006719 11006728 11006736 11006738 11006740 11006773 11006792 11006810 11006812 11006828 11006877 11006926 11006962 11006963 11007031 11007045 11007047 11007058 11007063 11007070 11007072 11007078 11007080 11007097 11007112 11007160 11007161 11007163 11007172 11007179 11007286 11007296 11007324 11400177 11400178 11400200 11400224 11400230 11400233 11400234 11400249 11400289 11400296 11400459 11400473 61750273 61758922 61768186 61771840 61771842 61776962 61776964 61776966 61777574 61777575 61777578 61777590 61777594 61777595 61777597 61782540 617
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States