RePlant® Zirconia Abutment Base 6035-30CBRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307114024), received between Dec 14, 2018 and Jan 15, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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 18, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), A 6035-30CB DENTAL ABUTMENT BASE DID NOT FIT THE RESPECTIVE ANALOG. THE LABEL WAS CORRECT, BUT THE INCORRECT PART WAS RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8251171 ↗MalfunctionJan 15, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), A 6035-30CB DENTAL ABUTMENT BASE DID NOT FIT THE RESPECTIVE ANALOG. THE LABEL WAS CORRECT, BUT THE INCORRECT PART WAS RECEIVED.
Patient problems: No Patient Involvement
MAUDE report 8251092 ↗MalfunctionDec 14, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), AN ABUTMENT BASE OF THE WRONG SIZE WAS IN A CORRECTLY ORDERED PACKAGE. THE PROBLEM WAS DISCOVERED WHILE UNPACKING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8166322 ↗
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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