Events

Recall of PROVIDE IMPRESSION COPING KITS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet 3i, LLC.

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
    72446
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2016
  • Event Initiated Date
    2015-09-21
  • Event Date Posted
    2016-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141247
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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