TRIGEN 71692806Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010648204), received between Feb 21, 2026 and Feb 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100107); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 21, 2026Failure to Align

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE GUIDE OF THE SURESHOT META SET STOP WAS MIS CALIBRATED BY 10° OF ROTATION. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED PRODUCT. THE MISCALIBRATION DID NOT IMPACT THE PATIENT, THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME AS THE REDUCTION WAS ADEQUATE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410435 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100107. One submission often covers many models, so check the product and lot details in each record.

• Z-0411-2011 · Oct 15, 2010 · Terminated
  smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization syst