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Legacy4 ImplantRecalls & reported problems across all models

Implant Direct Sybron Manufacturing LLC · 58 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1,786
Deaths reported
0
Injuries reported
1,751
Recalls
0

We found 58 models of Legacy4 Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 1,786 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2018 and Sep 30, 2026 — classified as 1,751 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (971 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 11 reportsDec 2023: 7 reportsJan 2024: 21 reportsFeb 2024: 5 reportsMar 2024: 18 reportsApr 2024: 12 reportsMay 2024: 12 reportsJun 2024: 8 reportsJul 2024: 1 reportsAug 2024: 18 reportsSep 2024: 5 reportsOct 2024: 28 reportsNov 2024: 8 reportsDec 2024: 10 reportsJan 2025: 10 reportsFeb 2025: 5 reportsMar 2025: 7 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 8 reportsNov 2025: 32 reportsDec 2025: 71 reportsJan 2026: 10 reportsFeb 2026: 4 reportsMar 2026: 10 reportsApr 2026: 13 reportsMay 2026: 10 reportsJun 2026: 5 reportsJul 2026: 1 reportsAug 2026: 4 reportsSep 2026: 3 reportsOct 2026: 0 reports20242025202671
Last 36 months. The most recent month may be incomplete.

Most reported Legacy4 Implant problems

Device problems

  • Failure to Osseointegrate971
  • Osseointegration Problem244
  • Loss of Osseointegration219
  • Positioning Failure159
  • Positioning Problem87
  • Fracture31
  • Separation Failure23
  • Malposition of Device13

Patient problems

  • Failure of Implant1,507
  • Osteopenia/ Osteoporosis309
  • Inflammation264
  • Inadequate Osseointegration227
  • Unspecified Infection220
  • Granuloma178
  • Pain166
  • No Clinical Signs, Symptoms or Conditions159

Legacy4 Implant models

58 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Legacy4 Implant adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Implant Direct Sybron Manufacturing LLC products

All Implant Direct Sybron Manufacturing LLC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page