OSSEOTITE® CERTAIN® 2 XIFOSS411Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN 2 (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Certain 2 dental implant is a root-form screw placed in the jaw to support a tooth. The 31 reports mostly describe implants and screws fracturing or breaking during removal, along with bone loss around the implant and infection at the site; all31 reports involved injuries and no deaths were reported. There are no recalls naming this device. Reports fell sharply in the past 12 months, from 9 to 1.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00844868023159), received between Aug 25, 2020 and Aug 1, 2025 — classified as 30 injuries.
The most frequently reported specific device problem is “Fracture” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem24
- Fracture6
Patient problems
- Unspecified Infection15
- Osteolysis14
- Pain14
- Inflammation5
- No Clinical Signs, Symptoms or Conditions5
- Abscess2
- Bone Fracture(s)2
- Edema1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO FRACTURE. A LOSS OF INTEGRATION WAS NOTED, IN ADDITION TO IMPLANT MOBILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688926 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITES #26 & #14.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22536062 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22246057 ↗InjuryApr 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21877652 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 43 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21592453 ↗InjuryFeb 18, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21399780 ↗InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21211034 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. BONE LOSS AROUND IMPLANT. TOOTH NUMBER 30.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21196197 ↗InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BONE LOSS WAS REPORTED AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. UNKNOWN TOOTH NUMBER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21169415 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 44 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19713277 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling/ Edema
MAUDE report 19706884 ↗InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO BONE LOSS. A NEW IMPLANT WAS PLACED WHEN THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 18826064 ↗InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18231965 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #5, WITH ASSOCIATED PAIN AND ABSCESS. UPON X-RAY FOUND IMPLANT WAS MOBILE; THEREFORE, IT WAS REMOVED.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 17981214 ↗InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT BONE LOSS AT IMPLANT TOOTH SITE #29. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 17954608 ↗InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 (UNIVERSAL) WAS REMOVED DUE TO AN INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN
Patient problems: Pain; Unspecified Infection
MAUDE report 17884718 ↗InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 17317444 ↗InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOO MUCH VESTIBULAR DRILLING, FRACTURE OF THE BONE WALL WHEN PLACING THE IMPLANTS, SO NO PRIMARY STABILITY. PROCEDURE NOT COMPLETED.
Patient problems: Bone Fracture(s)
MAUDE report 16989236 ↗InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI-IMPLANTITIS WITH INFLAMMATION AND PAIN AT TOOTH SITE 20.
Patient problems: Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 16875749 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT PERFORATED ON SITE #4 AND IT HAD TO BE REMOVED.
Patient problems: Bone Fracture(s)
MAUDE report 15428376 ↗InjuryJul 8, 2022Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE #36, FOUR (4) YEARS AFTER CROWN PLACEMENT. THE PATIENT CAME WITH THE IMPLANT FRACTURED AT THE COLLAR. A NEW IMPLANT WAS PLACED THREE (3 )MONTHS AFTER THE IMPLANT'S REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14956959 ↗InjuryJul 1, 2022Fracture; Fracture
IT WAS REPORTED THAT IMPLANT WAS PLACED WITHOUT ANY ISSUES DURING SURGICAL AND PROSTHETIC PHASE. PATIENT CAME TO REGULAR CHECK UPS. ONE DAY CROWN FELL AND DOCTOR NOTICED THAT THE REASON WAS THE IMPLANT FRACTURE. IMPLANT WAS REMOVED AND A NEW ONE WAS PLACED IN THE SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14884091 ↗InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN FEELING PAIN AT IMPLANT SITE #19. THE IMPLANT WAS REMOVED DUE TO INFECTION AND ANTIBIOTICS WERE PRESCRIBED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 14632485 ↗InjuryMar 17, 2022Fracture; Fracture
IT IS REPORTED THE IMPLANT FRACTURED AND WAS REMOVED. PAIN IS REPORTED AS A CONSEQUENCE. TOOTH LOCATION # 9 (UNIVERSAL). THE SITE WAS GRAFTED WITH XENOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Pain
MAUDE report 13801394 ↗InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITES # 5 & 6 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 12917951 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page