Paltop 21-70010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290108695540), received between Nov 11, 2025 and Aug 3, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K112795); 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Failure to Osseointegrate

  Failure of osseointegration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111316 ↗
• InjuryFeb 22, 2026Failure to Osseointegrate

  FAILED TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24410460 ↗
• InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILED TO OSSEOINTEGRATE.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 23526494 ↗
• InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILED TO OSSEOINTEGRATE.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 23526388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112795. One submission often covers many models, so check the product and lot details in each record.

• Z-0019-2020 · May 30, 2019 · Terminated
  Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
• Z-1062-2019 · Feb 22, 2019 · Terminated
  Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
• Z-1064-2019 · Feb 22, 2019 · Terminated
  Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
• Z-1061-2019 · Feb 22, 2019 · Terminated
  Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
• Z-1063-2019 · Feb 22, 2019 · Terminated
  Paltop 1.25 Hex Drivers, Long Part Number: 60-70101