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Crédits
Devices
EP Healing abutment
Modèle / numéro de série
Lot Number: 560988
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide.
Description du dispositif
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Manufacturer
Biomet 3i
1 Event
Rappel de EP Healing abutment
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Fabricant
Biomet 3i
Adresse du fabricant
Biomet 3i, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
Source
USFDA
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Device Recall Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)
Modèle / numéro de série
Lot # 1152118
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) || Item: IWTH52 || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H)
Modèle / numéro de série
Lot # 1153081
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) || Item: IWTH54 || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H)
Modèle / numéro de série
Lot # 1150836
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) || Item: IWTH564 || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall EP Healing Abutment
Modèle / numéro de série
Items: MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676 and WTH678.
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
EP Healing Abutment || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H)
Modèle / numéro de série
Lot No. 1152783
Classification du dispositif
Dental Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description du dispositif
Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) || Item: ITHA52 || Dental implants
Manufacturer
Biomet 3i, LLC
2 en plus
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