T3® PRO Immediate Molar Implant T3PIM7D10LRecalls & reported problems
ZimVie US Corp LLC · T3 PRO Immediate Molar Implant 7mmD, 10mmL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868047575), received between Sep 15, 2025 and Apr 21, 2026 — classified as 3 injuries.
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 Problem3
Patient problems
- Osteolysis2
- Unspecified Infection2
- Hyperresponsive to stimuli1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE HEALING, AFTER A TORQUE TEST WITH A TEMPORARY CROWN BEING PLACED, THE PATIENT COMPLAINED OF PAIN AROUND THE IMPLANT AT TOOTH SITE #19. THE PATIENT REQUESTED THE IMPLANT TO BE REMOVED THEN RE-EVALUATE REPLACEMENT OF A NEW IMPLANT AFTER THE SITE HEALS.
Patient problems: Pain
MAUDE report 24938062 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 LOST INTEGRATION COMPLETELY AND THE IMPLANT WAS NOTED TO BE LOOSE AFTER OSTEOTOMY. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT IN APPROXIMATELY FOUR MONTH. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24889690 ↗InjurySep 15, 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. UPON POST OP CHECK, SITE LOOKED INFLAMED AND NOT HEALING PROPERLY. IMPLANT WAS REMOVED, SITE WAS CURETTED AND IRRIGATED. ALLOGRAFT WAS PACKED INTO SITE WITH OVERLYING COLLAPLUG. TOOTH #19. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SENSITIVITY.
Patient problems: Hyperresponsive to stimuli; Osteolysis; Unspecified Infection
MAUDE report 23051133 ↗
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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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