BioHorizons MDL2513ZRecalls & reported problems
Biohorizons Implant Systems, Inc · MDL Implant Ossean 2.5 x 13mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons MDL implant is a small screw-shaped dental implant used to replace a missing tooth. The 56 reports mostly describe the implant failing to bond with the surrounding bone, so it doesn't integrate and has to be taken back out, sometimes within a day or two of surgery; one report mentions a fracture. No deaths were reported, and all 56 reports involve injuries. No recalls name this device, and reports have dropped sharply, from 26 in the prior 12 months to 7 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
- 56
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00847236014032), received between Feb 16, 2024 and May 27, 2026 — classified as 56 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 Problem6
- Fracture1
- Loss of Osseointegration1
Patient problems
- Insufficient Information56
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 25302076 ↗InjuryMar 9, 2026Failure to Osseointegrate
InjuryMar 9, 2026Failure to Osseointegrate
InjuryFeb 12, 2026Failure to Osseointegrate
InjuryFeb 12, 2026Failure to Osseointegrate
InjuryDec 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 10, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22177940 ↗InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20799620 ↗
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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