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Devices
EP Healing abutment
모델명 / 제조번호(시리얼번호)
Lot Number: 560988
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide.
제품 설명
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Manufacturer
Biomet 3i
1 Event
EP Healing abutment 의 리콜
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제조사
Biomet 3i
제조사 주소
Biomet 3i, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건
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여기
Device Recall Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)
모델명 / 제조번호(시리얼번호)
Lot # 1152118
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
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.
제품 설명
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)
모델명 / 제조번호(시리얼번호)
Lot # 1153081
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
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.
제품 설명
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)
모델명 / 제조번호(시리얼번호)
Lot # 1150836
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
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.
제품 설명
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
모델명 / 제조번호(시리얼번호)
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.
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
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.
제품 설명
EP Healing Abutment || Dental implants
Manufacturer
Biomet 3i, LLC
Device Recall Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H)
모델명 / 제조번호(시리얼번호)
Lot No. 1152783
의료기기 분류등급
Dental Devices
의료기기 등급
2
이식된 장치?
Yes
유통
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.
제품 설명
Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) || Item: ITHA52 || Dental implants
Manufacturer
Biomet 3i, LLC
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