OSSEOTITE® CERTAIN® 2 XIFOSS410Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 10MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN 2 (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Certain dental implant is a small titanium post placed in the jawbone to support a replacement tooth. The 23 reports on file mostly describe infections with pain, swelling, and pus around the implant that led to its removal, plus a few implants that fractured near the top. There were no deaths, but 22 injuries were reported. No recalls name this device.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00844868023142), received between Jan 31, 2020 and May 11, 2026 — classified as 22 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
- Fracture6
- Mechanical Problem1
Patient problems
- Unspecified Infection11
- Pain8
- Osteolysis4
- No Clinical Signs, Symptoms or Conditions3
- No Information3
- Erosion2
- Swelling/ Edema2
- Abscess1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #35 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND PURULENCE.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25135576 ↗InjuryJun 19, 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 INFECTION. CUSTOMER REPORTED PATIENT PRESENTED WITH PAIN AND SWELLING. IMPLANT WAS REMOVED AND AREA DEBRIDED. PATIENT WAS PUT ON CLINDAMYCIN, TOOTH 18. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 22292358 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN WITH EXTREME PAIN AROUND THE IMPLANT AT TOOTH LOCATION # 29. THE IMPLANT WAS FOUND INFECTED AND WAS REMOVED. THE PATIENT WAS ALSO PLACED ON ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Pain; Unspecified Infection
MAUDE report 22151559 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 21606651 ↗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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21211272 ↗MalfunctionSep 27, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED UNABLE TO SEAT ABUTMENT DUE TO DAMAGED INTERNAL CONNECTION. AFTER INTEGRATION, WE COULD NOT GET AN OEM ABUTMENT TO SEAT. WE THEN ATTEMPTED NON-ENGAGING COMPONENTS WHICH CONTINUED TO LOOSE. WE THEREFORE HAD TO REMOVE THE IMPLANT DUE TO DAMAGED INTERNAL CONNECTION. A DIFFERENT IMPLANT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 20321258 ↗InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 46 WAS REMOVED AFTER 3 MONTHS DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19926095 ↗InjuryMay 13, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 HAD A FRACTURED IMPLANT COLLAR. THE IMPLANT COLLAR WAS BROKEN/FRACTURED PER INDICATED: THE IMPLANT FRACTURED NEAR THE COLLAR. PATIENT DOES NOT RECALL ANY UNUSUAL EVENT (I.E. ACCIDENT BITING HARD FOOD ETC.)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19296792 ↗InjuryMar 28, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997949 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN HAD SOME DISCOMFORT AROUND THE IMPLANT AT TOOTH LOCATION #30. THE IMPLANT REMAINED IMPLANTED AND THE PATIENT WAS PLACED ON ANTIBIOTICS.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 17948858 ↗InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION # 45 WAS REMOVED DUE TO INFECTION. DURING THE STICHES REMOVAL, GINGIVAL ABSCESS WAS ALSO OBSERVED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 17479555 ↗InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: Inflammation; Osteolysis
MAUDE report 16725993 ↗InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #29 AND #30 WERE REMOVED DUE TO PAIN.
Patient problems: Pain
MAUDE report 15756570 ↗InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN FOR A TREATMENT APPOINTMENT AND WAS HAVING PAIN AROUND THE IMPLANT AT TOOTH LOCATION #20. THE PATIENT WAS PUT ON ANTIBIOTICS AND THE IMPLANT WAS REMOVED DUE TO INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 15708959 ↗InjuryFeb 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT FRACTURED RESULTING IN IT BEING REMOVED. TOOTH #19.
Patient problems: Failure of Implant
MAUDE report 13487107 ↗InjuryJan 24, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS FRACTURED. THE REMAINING PART OF THE IMPLANT WAS SURGICALLY REMOVED AND GRAFTED WITH ALLOGRAFT BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13332913 ↗InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 12338841 ↗InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO INFECTION. SWELLING AND ABSCESS WERE ALSO NOTED.
Patient problems: Abscess; Swelling/ Edema; Unspecified Infection
MAUDE report 12024870 ↗InjuryDec 7, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10957197 ↗InjuryNov 11, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10825285 ↗InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.
Patient problems: No Information
MAUDE report 10464426 ↗InjuryJan 31, 2020Adverse 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 INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 9655533 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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