Legacy™2 Implant 825211Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø5.2 x 11.5 Platform 4.5mmD · Class 2 · Implant
All models of Legacy2 Implant (78)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Implant Direct Legacy 2 implant is a screw-shaped implant placed into bone. Its 149 reports mostly describe the implant failing to fuse with the bone or lacking stability when placed, and some mention inflammation or infection. The reports include 147 injuries and no deaths. Reports rose to 12 in the last 12 months from 5 in the 12 months before. 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
- 150
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 10841307101444), received between Dec 20, 2018 and Sep 15, 2026 — classified as 148 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (69 reports).
2 other recalls cover devices cleared under the same FDA submission (K192221); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate69
- Positioning Failure25
- Osseointegration Problem22
- Loss of Osseointegration17
- Positioning Problem9
- Fracture4
- Premature Separation3
- Break1
Patient problems
- Failure of Implant129
- Inflammation29
- Osteopenia/ Osteoporosis23
- Unspecified Infection18
- Inadequate Osseointegration16
- Pain16
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient13
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780399 ↗InjuryAug 25, 2026Positioning Failure; Osseointegration Problem
Lack of stability during placement.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50440189 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 25696895 ↗InjuryJun 25, 2026Positioning Failure; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 25628691 ↗InjuryApr 16, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 24905383 ↗InjuryApr 14, 2026Positioning Failure
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873284 ↗InjuryMar 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 24558947 ↗InjuryFeb 6, 2026Positioning Failure
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283923 ↗InjuryJan 21, 2026Premature Separation
COMPONENT NOT RETAINED ON MATING PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132595 ↗InjuryNov 12, 2025Separation Failure; Insufficient Device Problem Information; Separation Failure; Insufficient Device Problem Information
COMPONENT DOES NOT DISENGAGE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23533738 ↗InjuryNov 5, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474629 ↗InjuryNov 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23474220 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23461297 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Numbness
MAUDE report 23442358 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 23436876 ↗InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 23436362 ↗InjuryJan 17, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert
LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21184091 ↗InjurySep 17, 2024Product Quality Problem; Product Quality Problem
InjuryAug 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19976018 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19967815 ↗InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Fibrosis; Granuloma; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 19961725 ↗InjuryAug 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 19945076 ↗InjuryJul 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 19659535 ↗InjuryJun 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19452995 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.
- Z-0197-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
- Z-0198-2022 · Sep 23, 2021 · Open, ClassifiedImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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