BioHorizons MDL2510SZRecalls & reported problems
Biohorizons Implant Systems, Inc · MDL Implant Single Ossean 2.5 x 10mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons dental implant has 81 FDA adverse event reports, describing mostly the implant failing to bond with the jawbone, with one fracture mentioned. There were no deaths and 80 injuries. No recalls name this device. Report volume fell from 59 to 16 in the past 12 months compared with the prior 12 months.
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
- 81
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00847236013950), received between Mar 1, 2024 and Jun 9, 2026 — classified as 80 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (71 reports).
1 other recall cover devices cleared under the same FDA submission (K070601, 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. 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 Osseointegrate71
- Use of Device Problem11
- Fracture1
- Loss of Osseointegration1
Patient problems
- Insufficient Information81
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 2, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25364064 ↗InjuryJun 2, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25364061 ↗InjuryApr 28, 2026Failure to Osseointegrate
InjuryMar 16, 2026Failure to Osseointegrate
InjuryMar 16, 2026Failure to Osseointegrate
InjuryMar 16, 2026Failure to Osseointegrate
InjuryMar 13, 2026Failure to Osseointegrate
InjuryMar 13, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24443480 ↗InjuryFeb 18, 2026Failure to Osseointegrate
InjuryFeb 12, 2026Failure to Osseointegrate
InjuryJan 16, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24096337 ↗InjuryDec 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K070601, 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 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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