BioHorizons MDL2511ZRecalls & reported problems
Biohorizons Implant Systems, Inc · MDL Implant Ossean 2.5 x 11.5mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons MDL dental implant is a small screw-shaped implant that anchors a replacement tooth in the jawbone. Most of the 56 reports describe the implant failing to fuse with the surrounding bone, so it has to be removed, sometimes within a day or two of surgery. All 56 involve injuries, with no deaths and no malfunctions noted, and no recalls name this device. Reports fell from 35 in the previous 12 months to 4 in the most recent 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
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00847236013998), received between Feb 24, 2024 and Aug 7, 2026 — classified as 57 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (50 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 Osseointegrate50
- Use of Device Problem10
- Loss of Osseointegration1
Patient problems
- Insufficient Information57
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Failure to Osseointegrate
InjuryMar 22, 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 24446399 ↗InjuryDec 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 29, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22109626 ↗InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 12, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21364484 ↗InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 17, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21166951 ↗InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 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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