BioHorizons MDL2511SZRecalls & reported problems
Biohorizons Implant Systems, Inc · MDL Implant Single 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 root form used to anchor a replacement tooth in the jawbone. The 31 reports mostly describe the implant failing to fuse with the surrounding bone, so it does not become stable, along with a few reports of the device being used in an unintended way. All 31 reports involved an injury, and no deaths were 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00847236013981), received between Feb 24, 2024 and Jun 9, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (24 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 Osseointegrate24
- Use of Device Problem5
- Osseointegration Problem1
Patient problems
- Insufficient Information29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Failure to Osseointegrate
InjuryMar 22, 2026Failure to Osseointegrate
InjuryMar 9, 2026Failure to Osseointegrate
InjuryFeb 9, 2026Failure to Osseointegrate
InjurySep 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21988212 ↗InjuryMay 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21316033 ↗InjuryJan 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21272952 ↗InjuryJan 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20251373 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 6, 2024Failure 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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