Hex-LockRecalls & reported problems across all models
ZimVie US Corp LLC · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 13 models of Hex-Lock by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2020 and Feb 20, 2026 — classified as 10 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (22 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 Hex-Lock problems
Device problems
- Unintended Movement22
- Fracture14
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Information5
- Inflammation1
- Pain1
Hex-Lock models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hex-Lock® HLA4/5IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Hex-Lock® HLA3/4IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Hex-Lock® HLA3/5IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Hex-Lock® ZOA342SABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Hex-Lock® ZOA441SABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Hex-Lock® HLA4/4IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Hex-Lock® HLA4/6IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Hex-Lock® HLA5/6IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Hex-Lock® SA451ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- Hex-Lock® ZOA341AABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- Hex-Lock® ZOA341SABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- Hex-Lock® ZOA343SABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- Hex-Lock® ZOA441AABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
Recent Hex-Lock adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399736 ↗MalfunctionFeb 13, 2026Unintended Movement
IT WAS REPORTED THAT THE PROSTHESIS WAS PLACED AND TIGHTENED PERMANENTLY WITH 30 NCM AT TOOTH SITE #12. AFTER A MONTH, THE CROWN WAS MOVING. UNFORTUNATELY, IT WASN'T THE CROWN THAT WAS MOVING, BUT THE ABUTMENT. THE PATIENT RETURNED SEVERAL TIMES WITH THE SAME PROBLEM BUT THE ISSUE COULDN'T BE SOLVED. IN (B)(6), DENTIST REPLACED IT BECAUSE IT SEEMED LIKE THE FRICTION FIT CONNECTION WAS NOT FITTING CORRECTLY. PATIENT REFERRED PAIN. ABUTMENT WAS PLACED ON (B)(6) 2025 AND REMOVED ON (B)(6) 2026. THIS EVENT IS CREATED TO REPRESENT THE FIRST LOOSENING.
Patient problems: Pain
MAUDE report 24330892 ↗MalfunctionDec 5, 2025Fracture; Fracture
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE 46 WAS REMOVED DUE TO A FRACTURE AT THE IMPLANT COLLAR. PATIENT ATTENDED AS AN EMERGENCY DUE TO LOSS OF THE CROWN ON IMPLANT 46. EXAMINATION REVEALED A FRACTURED PORTION OF THE IMPLANT COLLAR EMERGING AT THE GINGIVAL LEVEL, WITH THE ABUTMENT SCREW FRACTURED INSIDE THE IMPLANT. THE PATIENT REPORTED NO PAIN. PROCEDURE WAS NOT COMPLETED. THIS COMPLAINT REFERS TO THE SCREW ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725461 ↗MalfunctionAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT SCREW IN THE IMPLANT OF TOOTH SITE #34 (FDI) WAS FRACTURED. THE IMPLANT WAS REPORTED TO BE INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22887926 ↗MalfunctionAug 21, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22865017 ↗MalfunctionAug 20, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853638 ↗MalfunctionJun 13, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED A MOBILE PROSTHESIS DUE TO LOOSENINGS THAT FINALLY LED TO THE RETENTION SCREW BREAKAGE ON TOOTH SITE #36. PROCEDURE WAS COMPLETED WITH ANOTHER TIBASE WITH NO IMPACT ON THE PATIENT REPORTED. THIS EVENT REPRESENTS THE 1ST LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201203 ↗InjuryMar 31, 2025Fracture; Fracture
IT WAS REPORTED THAT THE CROWN WAS LOOSE AND THE ABUTMENT SCREW WAS FOUND TO BE BROKEN. THE IMPLANT WAS ALSO LOOSE, THEREFORE THE IMPLANT AND ABUTMENT WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21730080 ↗InjuryMay 29, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19415304 ↗InjuryMay 20, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AT A FOLLOW UP VISIT, THE IMPLANT AT TOOTH LOCATION #16 (FDI) WAS REMOVED BECAUSE THE ABUTMENT ON THE IMPLANT HAD LOOSENED TO THE POINT THAT THE SCREWS HAD FALLEN OUT AND BROKEN, PREVENTING FORCEFUL LOCKING AND LEADING TO FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351511 ↗InjuryMay 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SCREW AT TOOTH SITE #26 FRACTURED. IT WAS REPORTED THAT THE PATIENT CAME IN WITH CROWN IN HAND; SAYS IT BROKE OFF. THE SCREW BROKE OFF AT THE HEAD. UNABLE TO REMOVE THE THREAD PART OF THE SCREW. A WEEK FOLLOWING HAD TO REMOVE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19329650 ↗InjuryMay 2, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 HAD TO BE REMOVED AS THE CROWN WAS LOOSE DUE TO THE ABUTMENT SCREW FRACTURING. THE IMPLANT WAS REMOVED AFTER TRYING TO REMOVE THE FRACTURED SCREW AND NOT BEING ABLE TO. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19231215 ↗InjuryMar 22, 2024Fracture; Fracture
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18957760 ↗InjuryMar 21, 2024Fracture; Fracture
UPON FOLLOW UP, THE LOT NUMBER WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18953957 ↗MalfunctionJan 11, 2024Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18495887 ↗
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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