RePlant® Zirconia Abutment Base 6050-30CBRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10841307114048), received between Dec 14, 2018 and Jan 3, 2019 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (10 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 Problem10
Patient problems
- No Patient Involvement10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE CERAMIC ABUTMENT BASE DID NOT FIT THE 3.5MM PLATFORM AS INTENDED. RATHER, IT FIT THE 5.0MM PLATFORM. THE COMPLAINT WAS DISCOVERED DURING LABORATORY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8214734 ↗MalfunctionJan 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE CERAMIC ABUTMENT BASE DID NOT FIT THE 3.5MM PLATFORM AS INTENDED. RATHER, IT FIT THE 5.0MM PLATFORM. THE COMPLAINT WAS DISCOVERED DURING LABORATORY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8214670 ↗MalfunctionJan 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE CERAMIC ABUTMENT BASE DID NOT FIT THE 3.5MM PLATFORM AS INTENDED. RATHER, IT FIT THE 5.0MM PLATFORM. THE COMPLAINT WAS DISCOVERED DURING LABORATORY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8214612 ↗MalfunctionJan 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE CERAMIC ABUTMENT BASE DID NOT FIT THE 3.5MM PLATFORM AS INTENDED. RATHER, IT FIT THE 5.0MM PLATFORM. THE COMPLAINT WAS DISCOVERED DURING LABORATORY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8214537 ↗MalfunctionJan 3, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE CERAMIC ABUTMENT BASE DID NOT FIT THE 3.5MM PLATFORM AS INTENDED. RATHER, IT FIT THE 5.0MM PLATFORM. THE COMPLAINT WAS DISCOVERED DURING LABORATORY PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8214338 ↗MalfunctionDec 18, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
PER COMPLAINT (B)(4), THE PACKAGED PRODUCT WAS SUSPECTED TO CONSIST OF AN INCORRECTLY SIZED TITANIUM BASE WITH THE CORRECTLY SIZED SCREW. THE ABUTMENT BASE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8174528 ↗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 8166500 ↗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 8166468 ↗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 8166460 ↗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 8166453 ↗
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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