Z5-BL Z5-BL-3610Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-BL (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5-BL dental implant is a root-form screw placed in the jawbone, sold with a cover screw and healing cap. The 29 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond once it had formed, along with two reports of fracture and tissue injury or inflammation at the site. Reports mention 13 injuries and no deaths. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07640166768494), received between May 21, 2024 and Sep 30, 2026 — classified as 15 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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
- Failure to Osseointegrate23
- Loss of Osseointegration6
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Unspecified Tissue Injury11
- Inflammation5
- Implant Pain1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943228 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943221 ↗InjuryAug 26, 2026Failure to Osseointegrate
InjuryAug 26, 2026Failure to Osseointegrate
MalfunctionJun 25, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618798 ↗MalfunctionJun 25, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618787 ↗MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203027 ↗MalfunctionMar 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702090 ↗MalfunctionMar 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702089 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159132 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159099 ↗MalfunctionJan 23, 2026Loss of Osseointegration
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: Inflammation
MAUDE report 23301770 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278184 ↗MalfunctionOct 15, 2025Fracture; Fracture
MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932512 ↗MalfunctionApr 17, 2025Fracture; Fracture
MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631805 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616440 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Unspecified Tissue Injury
MAUDE report 21283492 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Unspecified Tissue Injury
MAUDE report 21283272 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
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 18, 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