CERTAIN® ILPC442Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868021216), received between Dec 7, 2022 and Nov 21, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Fracture; Fracture
IT WAS REPORTED THE ABUTMENT FRACTURE AT THE THREADED PART INSIDE THE IMPLANT AT TOOTH SITE #16. SCREW WAS COMPLETELY REMOVED. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615516 ↗MalfunctionNov 22, 2024Fracture; Fracture
IT WAS REPORTED A SCREW FRACTURE OF THE ABUTMENT OBSERVED DURING A URGENCY VISIT. THE PATIENT WENT TO THE CLINIC WITH A LOOSE CROWN AT TOOTH SITE 46 AND THE ABUTMENT WAS OBSERVED FRACTURED. ABUTMENT PLACEMENT ON (B)(6) 2023 / ABUTMENT EXTRACTION ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756069 ↗MalfunctionFeb 3, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16293375 ↗MalfunctionDec 7, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT CAME WITH THE CROWN IN HIS HAND DUE TO THE FRACTURE OF THE THROUGH SCREW OF THE TRANSEPITHELIAL ABUTMENT. THE DOCTOR REPORTS THAT THE TORQUE USED WAS 15NW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15930491 ↗
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- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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