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ScrewIndirect® Implant 405708Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant

All models of ScrewIndirect Implant (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307104858), received between Mar 3, 2020 and Mar 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K061319); 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.

Most reported problems

Device problems

  • Inaccurate Information1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 3, 2020Inaccurate Information; Inaccurate Information

    AS PER COMPLAINT (B)(4), DURING A REVIEW OF FINISHED GOODS IN THE IMPLANT DIRECT DISTRIBUTION CENTER IT WAS DISCOVERED THAT A CAP LABEL CONTAINED THE WRONG PART NUMBER & PLATFORM DIAMETER. THE PRODUCT INFORMATION ON THE LABEL WAS PRINTED AS 423208 PART NUMBER AND 4.0MM DIAMETER. THE PRODUCT INFORMATION ON THE LABEL SHOULD HAVE BEEN 405708 PART NUMBER AND 5.0MM DIAMETER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9782223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.

  • Z-0010-2020 · Aug 7, 2018 · Terminated
    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
  • Z-2376-2018 · May 18, 2018 · Terminated
    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
  • Z-2125-2017 · May 2, 2017 · Terminated
    Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
  • Z-2320-2016 · Jul 5, 2016 · Terminated
    RePlant Angled Abutment Part Number 6050-52-60

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page