BioHorizons CTR3310Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.3 x 10.5mm, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons CTR3310 tapered conical dental implant is a root-form screw placed in the jaw. The 33 reports mostly describe the implant failing to fuse with the surrounding bone, so it has to be taken back out, sometimes within a day or two of surgery. No deaths were reported; all 33 reports involved injuries. There are no recalls naming this device. Reports rose sharply in the past 12 months, from 9 to 24.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00847236024277), received between Dec 27, 2024 and Sep 10, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate22
- Use of Device Problem13
Patient problems
- Insufficient Information35
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710428 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710423 ↗InjuryAug 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50268406 ↗InjuryAug 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50268383 ↗InjuryAug 12, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryApr 15, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 3, 2026Failure to Osseointegrate
InjuryMar 18, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24634229 ↗InjuryMar 18, 2026Use of Device Problem
InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 12, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryJan 23, 2026Failure to Osseointegrate
InjuryJan 18, 2026Use of Device Problem
DRIVER BROKE OFF INSIDE THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 24106790 ↗InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23878032 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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