BioHorizons LPYR3512Recalls & reported problems
Biohorizons Implant Systems, Inc · Internal Implant RBT, Laser-Lok 3.5 x 12mm, 3.5 Platform · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847236003753), received between Feb 24, 2024 and Sep 21, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (20 reports).
1 other recall cover devices cleared under the same FDA submission (K073268); 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 Osseointegrate20
- Use of Device Problem2
Patient problems
- Insufficient Information20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjuryAug 21, 2026Failure to Osseointegrate
InjuryJun 23, 2026Failure to Osseointegrate
InjuryMay 20, 2026Use of Device Problem; Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 25236624 ↗InjuryMay 20, 2026Use of Device Problem; Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 25236529 ↗InjuryMay 6, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 13, 2026Failure to Osseointegrate
InjuryMar 9, 2026Failure to Osseointegrate
InjuryJan 5, 2026Failure to Osseointegrate
InjuryJan 5, 2026Failure to Osseointegrate
InjuryJul 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K073268. One submission often covers many models, so check the product and lot details in each record.
- Z-0391-2016 · Oct 30, 2015 · TerminatedRBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
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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