BioHorizons TRXP5810Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 5.8 x 10.5mm, RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered dental implant is a screw-shaped root-form implant used to anchor a replacement tooth in the jawbone. The 35 reports mostly describe the implant not fusing properly with the surrounding bone, so it does not become stable, along with a smaller number of reports about how the device was used. All 35 reports involve injuries, with no deaths reported. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00847236012809), received between Mar 21, 2024 and Aug 14, 2026 — classified as 34 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 reports).
1 other recall cover devices cleared under the same FDA submission (K121787, K223697); they may or may not involve this specific model.
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 Osseointegrate28
- Use of Device Problem7
Patient problems
- Insufficient Information34
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryApr 27, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 16, 2026Failure to Osseointegrate
InjuryMar 11, 2026Failure to Osseointegrate
InjuryJan 29, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24212874 ↗InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23810806 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22080969 ↗InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 28, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21720746 ↗InjuryMar 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21517598 ↗InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K121787, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
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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