CERTAINRecalls & reported problems across all models
ZimVie US Corp LLC · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 328
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 33 models of CERTAIN by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 328 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2019 and Sep 30, 2026 — classified as 23 injuries, 305 malfunctions.
The most frequently reported specific device problem is “Fracture” (276 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CERTAIN problems
Device problems
- Fracture276
- Unintended Movement28
- Separation Failure13
- Adverse Event Without Identified Device or Use Problem4
- Separation Problem4
- Positioning Failure3
- Loose or Intermittent Connection2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions264
- No Information42
- Pain9
- Inflammation7
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Failure of Implant4
- Discomfort3
CERTAIN models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERTAIN® ILRGHTIMPLANT, ENDOSSEOUS, ROOT-FORM93 reports
- CERTAIN® IUNIHTABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- CERTAIN® ILPC442UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS29 reports
- CERTAIN® ILPC342UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS16 reports
- CERTAIN® ILPC444UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS15 reports
- CERTAIN® IIPDTULAccessories, Implant, Dental, Endosseous13 reports
- CERTAIN® ILPC443UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS12 reports
- CERTAIN® ILPC343UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS12 reports
- CERTAIN® ILPC441UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS11 reports
- CERTAIN® ILPC341UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS11 reports
- CERTAIN® ILPAC4330ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS7 reports
- CERTAIN® IMUCC2TABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- CERTAIN® ILPC442ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- CERTAIN® IUNAB2TABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® ILPC344UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® ILPAC3417ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® ILPAC4417ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- CERTAIN® ISHA44ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® ILPC341ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® ILPC444ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® IRE200UACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® ILPAC3330ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® ILPAC4530ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- CERTAIN® IIIC41ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® IIPDTLACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® IMPDTSACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® IMUCG2CABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® ILPC542UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® ILPC541UABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® ILPC344ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® ILPC443ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® ILPAC4217ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- CERTAIN® IIPDTUSAccessories, Implant, Dental, Endosseous1 report
Recent CERTAIN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
It was reported that the abutment fractured at the screw part. Abutment placed on (b)(6) 2026 and removed on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945475 ↗MalfunctionSep 29, 2026Fracture
It was reported the patient presented with the crown and fractured screws. The screws had fractured at the head, with the fractured head remaining inside the crown, while the remaining portion of the screws had not only become detached but had also unscrewed and was found in the patient¿s mouth. Tooth site 36. Placed on (b)(6)2026 and removed on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930159 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929410 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929393 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929373 ↗MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300035 ↗MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299922 ↗MalfunctionJul 10, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25777899 ↗MalfunctionJul 2, 2026Fracture
THE DOCTOR REPORTS THAT THE ITEM IS FRACTURED AT THE TIP. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25688225 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENTS FRACTURED BY THE SCREW PART AND WERE REMOVED. ABUTMENTS WERE PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. NO IMPACT ON THE PATIENT REPORTED. TOOTH LOCATION # 25+26. BONE DENSITY TYPE: IV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330884 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENTS FRACTURED BY THE SCREW PART AND WERE REMOVED. ABUTMENTS WERE PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. NO IMAPACT ON THE PATIENT REPORTED. TOOTH LOCATION # 25+26. BONE DENSITY TYPE: IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330741 ↗MalfunctionMay 14, 2026Fracture
IT WAS REPORTED THAT THE LOW PROFILE ABUTMENT SCREW FRACTURED WHEN PLACING IT. PROCEDURE NOT COMPLETED. TOOTH LOCATION 26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25169047 ↗MalfunctionMay 11, 2026Fracture
IT WAS REPORTED THAT THE MULTI UNIT ABUTMENT SCREWS FRACTURED. THE CLINICIAN WAS TRYING TO SCREW THE SCANBODY FOR TAKING IMPRESSIONS AND THE ABUTMENTS CAME TOGETHER. THE FRACTURED PART OF THE SCREW WAS REMOVED. TOOTH LOCATION 23 AND 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134426 ↗MalfunctionMay 8, 2026Fracture
IT WAS REPORTED THAT THE MULTI UNIT ABUTMENT SCREWS FRACTURED. THE CLINICIAN WAS TRYING TO SCREW THE SCANBODY FOR TAKING IMPRESSIONS AND THE ABUTMENTS CAME TOGETHER. THE FRACTURED PART OF THE SCREW WAS REMOVED. TOOTH LOCATION 23 AND 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123397 ↗MalfunctionApr 30, 2026Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CONICAL ABUTMENT WAS FRACTURED AT THE SCREW INSIDE IMPLANT ON TOOTH SITE #15. THE DOCTOR WAS ABLE TO REMOVE THE BROKEN FRAGMENT FROM THE IMPLANT. ABUTMENT PLACED ON (B)(6) 2023 AND REMOVED ON (B)(6) 2026. PATIENT SUFFERED FROM PAIN AND INFLAMMATION. PROCEDURE WAS COMPLETED. BONE DENSITY TYPE: III.
Patient problems: Inflammation; Pain
MAUDE report 25042524 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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