RePlus® Implant 704711Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.7mmD x 11.5mmL, 4.3mmD Platform · Class 2 · Implant
All models of RePlus Implant (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307104308), received between Jan 10, 2020 and Jun 10, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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, 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.
Most reported problems
Device problems
- Loss of Osseointegration4
Patient problems
- Failure of Implant4
- Osteopenia/ Osteoporosis2
- Fibrosis1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 14654656 ↗InjuryFeb 3, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 11272092 ↗InjuryDec 22, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis
MAUDE report 11053349 ↗InjuryJan 10, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9575213 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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