Legacy™ Straight Abutment Full-Contour Profile HLA3-5Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307111832), received between May 6, 2017 and May 25, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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.
Most reported problems
Device problems
- Failure to Osseointegrate1
- Fracture1
- Nonstandard Device1
Patient problems
- Failure of Implant2
- Impaired Healing2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 14497615 ↗InjuryOct 1, 2020Fracture; Fracture
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 10611689 ↗MalfunctionMay 6, 2017Nonstandard Device
THE HLA3-5 LEGACY LAB ABUTMENT UNIQUE IDENTIFIER ASSIGNED: HHE HLA3-5REV01 WAS OUT OF IMPLANT DIRECT SPECIFICATIONS, THERE WAS ONE RAW STOCK MANUFACTURED AND AFFECTED AND THE LOT WAS PLACED INTO 3 FINISHED GOODS LOTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6549890 ↗
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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