DS PrimeTaper 68017257Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532269950), received between Dec 16, 2025 and Sep 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792309 ↗
• MalfunctionApr 4, 2026Mechanical Jam

  CUSTOMER REPORTED LOSS OF INTERNAL SPRING WITHIN THE DRILL SLEEVE. 2026-03-12 DIOGP514: SPRING RING ISSUE ¿ CAPA NUMBER 2025-58. EVENT DEEMED NOT REPORTABLE IN COUNTRIES OTHER THAT THE US AS FOLLOW: EU: IT DOES NOT MEET THE CRITERIA OF A SERIOUS INCIDENT AND REFLECTS A DOCUMENTED INHERENT DEVICE RISK, THE EVENT IS DEEMED NOT REPORTABLE TO THE CA, BUT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE. BR: NOT MARKETED/ RELEASED. AU: THE EVENT OCCURRED OVERSEAS. CA: EVENT OCCURRED IN A FOREIGN COUNTRY WITH A CLASS II DEVICE. CN: THE EVENT DID NOT CAUSE A DEATH, NOR SEVERE INJURIES OR COULD HAVE POSSIBLY CAUSED SEVERE INJURIES/DEATH AND NO SERIOUS PUBLIC HEALTH THREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784378 ↗
• MalfunctionMar 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A FITTING PROBLEM DURING INITIAL USE. ANOTHER ITEM WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639483 ↗
• MalfunctionFeb 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION. THE WIRE OF AN UNUSED SLEEVE CAME OFF; THIS WAS DISCOVERED AFTER ATTACHING IT TO THE INSTRUMENT AND WAS DETERMINED TO HAVE OCCURRED AFTER STERILIZATION AND BEFORE SURGERY. THE SESSION WAS COMPLETED ON THE SAME DAY WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291627 ↗
• MalfunctionFeb 8, 2026Insufficient Device Problem Information

  CUSTOMER REPORTED A TOOL MALFUNCTION. THE WIRE OF AN UNUSED SLEEVES CAME OFF (CHECKED AFTER ATTACHING TO THE INSTRUMENT, THE ISSUE HAS BEEN DISCOVERED TO HAVE COME OFF AFTER STERILIZATION BEFORE SURGERY) . SESSION COMPLETED ON THE SAME DAY WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288327 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping; Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822198 ↗