BioHorizons CTA4610Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.6 x 10.5mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro dental implant is placed in the jawbone. The 283 reports mostly describe implants that did not fuse with the bone, and the reports give little patient detail. All 283 are injury reports, with no deaths. No recalls name this device, and reports rose to 188 in the last year from 94 in the year before.
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
- 297
- Deaths reported
- 0
- Injuries reported
- 297
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00847236024185), received between Oct 2, 2024 and Sep 29, 2026 — classified as 297 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (181 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
- Failure to Osseointegrate181
- Use of Device Problem129
Patient problems
- Insufficient Information297
Recent adverse event reports
The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 29, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50930445 ↗InjurySep 29, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 17, 2026Failure to Osseointegrate
InjurySep 17, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50741880 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours
Patient problems: Insufficient Information
MAUDE report 50721787 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721782 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721685 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710971 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710765 ↗InjurySep 10, 2026Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710694 ↗InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709491 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709216 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709200 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709127 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679450 ↗InjurySep 8, 2026Failure to Osseointegrate
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637102 ↗InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637093 ↗InjurySep 3, 2026Failure to Osseointegrate
InjurySep 1, 2026Failure 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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