NA 03.424.124Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982335944), received between Feb 25, 2026 and Mar 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 25, 2026Class IIOpen, Classified

   A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

   Z-1702-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TAP Ø2.4 TAPPING UP TO 90 L130 WAS ASSOCIATED WITH RECALL. THE EVENT INVOLVED A SINGLE DEVICE FROM THIS LOT. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT, AND THE DEVICE WAS AVAILABLE FOR RETURN. THE COMPLAINT DEVICE WAS REMOVED FROM USE AS A PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628370 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442466 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442464 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442462 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442461 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442459 ↗
• MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING A SET BUILDING PROCESS WHEN AN OPERATOR NOTICED THAT TWO PIECES WERE IDENTICAL BUT ETCHED WITH DIFFERENT PART NUMBERS. SPECIFICALLY, PARTS LABELED AS 03.424.124 WERE ETCHED ON 03.424.126 COMPONENTS, DESPITE DIFFERENCES IN THREAD SIZE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AS THE EVENT OCCURRED DURING SET-UP AND NOT DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442457 ↗