Devices

Device Recall Endosseous Dental Implant Accessories

Model / Serial
lot # 63145351, 63202941, 60646055, 62353334, 63316134
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
Product Description
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; || TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; || TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; || TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
Manufacturer
Zimmer Dental Inc
1 Event
- Recall of Device Recall Endosseous Dental Implant Accessories

Manufacturer

Zimmer Dental Inc

Manufacturer Address
Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
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

3 devices with a similar name

Learn more about the data here

Device Recall Endosseous Dental Implant Accessories

Model / Serial
lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
Product Description
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Manufacturer
Zimmer Dental Inc

Device Recall Endosseous Dental Implant Accessories

Model / Serial
lot # 63275811, 63238369, 63286562, 63240994, 63250273, 63286560, 62556219, 62607124, 62675252, 62445681, 62086170, 62679151, 62734003
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
Product Description
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; || MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; || IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; || IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; || IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; || IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; || MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; || IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
Manufacturer
Zimmer Dental Inc

Device Recall Endosseous Dental Implant Accessories

Model / Serial
lot # 62625167 63254074 63455622 63155008 63331292 63432495 63152070 63209557 63254047 62602470 63135399 63240239 63254023 61722820 62593186 62635420 63254006
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
Product Description
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; || WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; || WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; || WAXING COPING, CONT 4.5MM, REF ZOCWAX4S; || WAXING COPING, CONT, 5.5MM,ANG, REF ZOCWAX5A; || WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; || WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; || WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
Manufacturer
Zimmer Dental Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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