Esthetic Abutment 36669Recalls & reported problems
Nobel Biocare AB · Esthetic Abutment Conical Connection RP 1.5mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332747032598), received between Aug 22, 2019 and Aug 22, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Aug 9, 2019Terminated
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Z-1854-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled2
- Incomplete or Missing Packaging1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2019Incomplete or Missing Packaging; Component Misassembled; Incomplete or Missing Packaging; Component Misassembled
ON (B)(6) 2019 A CUSTOMER INFORMED NOBEL BIOCARE THAT PRODUCT MATERIAL NUMBER 36669 (ESTHETIC ABUTMENT CC RP 4.5MM), BATCH NUMBER 13075989, WAS PACKAGED WITH AN INCORRECT SCREW. THE CUSTOMER RETURNED THE PRODUCT, WHICH WAS RECEIVED BY THE MANUFACTURER ON (B)(6), 2019.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8921446 ↗MalfunctionAug 22, 2019Component Misassembled; Component Misassembled
NOBEL BIOCARE WAS VERBALLY INFORMED BY THE CUSTOMER ON THE (B)(6) 2019 THAT ORDERED MATERIAL #36669 (ESTHETIC ABUTMENT CC RP 1.5MM) BATCH #13075989 CONTAINED AN INCORRECT SCREW. THE CUSTOMER DID NOT RETURN THE ABUTMENT AN WILL USE A NEW SCREW INSTEAD OF THE INCORRECT SCREW THEY RECEIVED IN THE PACKAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS MOMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8921442 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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