NA 28.14.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024107755), received between Jun 14, 2019 and Jun 14, 2019 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K123347); 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 14, 2019Fracture; Fracture

  PLEASE REFER TO REPORT 0009613350 - 2019 - 00385.

  Patient problems: No Information

  MAUDE report 8699272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123347. One submission often covers many models, so check the product and lot details in each record.

• Z-1451-2019 · Apr 8, 2019 · Terminated
  Drill, 3.2x145mm, AO, Item Number 502015650
• Z-1433-2019 · Apr 8, 2019 · Terminated
  Drill, 2.7x125mm, AO, Item Number 502015217