simply Legacy™3 Implant 857010URecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of simply Legacy3 Implant (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841307108009), received between Oct 9, 2019 and Jul 8, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 Osseointegrate4
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Failure of Implant6
- No Consequences Or Impact To Patient3
- Fibrosis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
PRODUCT COMPL: FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19694836 ↗InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 16369903 ↗InjuryMar 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9887514 ↗InjuryMar 20, 2020Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9859242 ↗InjuryOct 9, 2019Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING HEALING PROCESS, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9171367 ↗
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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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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