Events

Rappel de PROVIDE IMPRESSION COPING KITS

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 Biomet 3i, LLC.

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
    72446
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0594-2016
  • Date de mise en oeuvre de l'événement
    2015-09-21
  • Date de publication de l'événement
    2016-01-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141247
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Cause
    Inadequate biocompatibility testing.
  • Action
    The firm, Biomet 3i, sent an "URGENT DEVICE RECALL NOTICE" letter dated September 16, 2015 to both Domestic and Foreign Customers via traceable courier. The letter described the product, problem and actions to be taken. The customers were instructed to review the notice and check your inventory for the affected units; immediately quarantine and remove all affected products from service; if you have product to return, call Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700 to obtain a CMP# and return affected product to Biomet 3i Returns, 4555 Riverside Dr., Palm Beach Gardens, FL 34410; complete and return the attached Business Reply Form via fax to: +1-561-514-6316 or email to: postmarket@biomet.com, and maintain a copy of the notice for your records. For assistance or any other questions that you may have, please contact Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700. The Complaints Department is available 8:00am to 6:00pm (Eastern), Monday through Friday.

Device

PROVIDE IMPRESSION COPING KITS
  • Modèle / numéro de série
    Model Number: PRK484, Lot Numbers: 929282 , 948311, 949496, 949497, 949668, 950083, 952452, 954303, 957220, 957368, 960733, 963052, 963054, 971802, 975153, 977973, 979767, 984897, 987880, 989210, 992599, 996689, 1001596, 1004143, 1008573, 1012089, 1013629, 1015576, 1023526, 1030628, 1033053, 1036120, 1041405,1044169,1046263, 1055914, 1055916, 1062672,1062819,1063241, 1064625,1065949, 1069639, 1071532, 1073172, 1075436, 1079918, 1083264, 1086406, 1089300, 1095122, 1098706, 1100723,1104907,1108327,1113200, 1119709, 1124780, 1128073, 1130255, 1131856, 1145310, 1147645, 1153461, 1161337, 1162496, 1166592, 1166593, 1166987, 1170183, 1171068, 1172744, 174130, 1176170, 1176650, 1177487, 1179602, 1181083, 1182414, 1183058, 1184585, 184586, 1185984;   Model Number: PRK485, Lot Numbers: 1117971, 1127401, 1148502, 1165797, 1170173, 1174218, 1181185, 1184583;  Model Number: PRK654, Lot Numbers: 929284, 948045, 952097, 952481, 952482, 957221, 957222, 957369, 961075, 961076, 966055, 971292, 976372, 978223, 979359, 984019, 987878, 991534, 996579, 1001594, 1004519, 1008716, 1013056, 1013628, 1016826, 1029923, 1031579, 1033052, 1036122, 1041538, 1051466, 1051616, 1053274, 1063078, 1063080, 1063531, 1064519, 1065947, 1069154, 1070308, 1070323, 1071531, 1072663, 1075435, 1077545, 1079499, 1080408, 1082647, 1087546, 1088471, 1091356, 1095135, 1101665,1105924,1108322, 1111753, 1122177, 1124967, 1127403, 1143157, 1146493, 1149132 , 1161341, 1165349, 1165799, 1170181, 1170182, 1170956, 1172743, 1176568, 1178724, 1179004, 1179951, 1181463, 1184279, 1184572, 1184573, 1186937;  Model Number: PRK655, Lot Numbers: 977274, 992602, 1005231, 1027142, 1031582, 1036123, 1049035, 1049035, 1055858, 1055858, 1059763, 1059763, 1060690, 1060690, 1063239, 1063239, 1071325, 1071325, 1086079, 1104105, 1104105,1128070, 1151635, 166984, 1166984, 1181738, 1181738.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
  • Description du dispositif
    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 || BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Adresse du fabricant
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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