NA 71106365SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556013021), received between Nov 3, 2020 and Nov 3, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K060736, K210837); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE OF THE 6.5MM X 165MM CAN SCREWS FT STAINLESS STEEL CAME STERILE PACKAGED WITH INCORRECT LABELING. THESE SCREWS ARE PARTIALLY THREADED BUT ARE LABELED AT FULLY THREADED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10781760 ↗
• MalfunctionNov 3, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE OF THE 6.5MM X 165MM CAN SCREWS FT STAINLESS STEEL CAME STERILE PACKAGED WITH INCORRECT LABELING. THESE SCREWS ARE PARTIALLY THREADED BUT ARE LABELED AT FULLY THREADED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10781724 ↗
• MalfunctionNov 3, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THREE OF THE 6.5MM X 165MM CAN SCREWS FT STAINLESS STEEL CAME STERILE PACKAGED WITH INCORRECT LABELING. THESE SCREWS ARE PARTIALLY THREADED BUT ARE LABELED AT FULLY THREADED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10781696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060736, K210837. One submission often covers many models, so check the product and lot details in each record.

• Z-0143-2022 · Sep 20, 2021 · Terminated
  6.5MMX165MM CANNULATED SCREW