OSSEOTITE® OSS320Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 3.75 X 20MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868013150), received between Sep 16, 2021 and Mar 7, 2025 — classified as 4 injuries.
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. 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
- 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.
InjuryMar 7, 2025Fracture; Fracture
IT WAS REPORTED A FRACTURE OF THE IMPLANT IN HALF AT TOOTH SITE 25. IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545972 ↗InjuryJul 2, 2024Fracture; Fracture
IT WAS REPORTED 2 FRACTURED IMPLANTS AT THE BODY OF A 4 IMPLANT-RETAINED OVERDENTURE. BOTH IMPLANTS WERE COMPLETELY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19653877 ↗InjuryJul 2, 2024Fracture; Fracture
IT WAS REPORTED 2 FRACTURED IMPLANTS AT THE BODY OF A 4 IMPLANT-RETAINED OVERDENTURE. BOTH IMPLANTS WERE COMPLETELY REMOVED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19653871 ↗InjurySep 16, 2021Fracture; Fracture
THE DOCTOR REPORTS A FRACTURE IN THE IMPLANT LOCATED IN DENTAL POSITION 26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12479535 ↗
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