TRIGEN 71642160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010478948), received between Jun 18, 2021 and Jun 18, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K981529); 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.

• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PLACING A INT HEX CAP SCREW 4.5MM X 60MM, THE DOCTOR MADE THE DECISION TO CHANGE IT FOR A SHORTER ONE, SINCE THE INITIAL SCREW WAS VERY LONG. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981529. One submission often covers many models, so check the product and lot details in each record.

• Z-0943-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for
• Z-0944-2013 · Feb 7, 2013 · Terminated
  INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for