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TRIGEN 71634440Recalls & reported problems

Smith & Nephew, Inc. · FEMORAL ANTEGRADE NAIL LIME 13MM X 40CM LEFT · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010392817), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K210980, 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

Device problems

  • Degraded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 21, 2021Degraded; Degraded

    IT WAS REPORTED THAT, DURING NAIL SURGERY, ONE (1) FAN LIME 13X40 LF WAS STRIPPED WHILE TAKING DRILL GUIDE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12201302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210980, K981529. One submission often covers many models, so check the product and lot details in each record.

  • Z-2456-2026 · Mar 16, 2026 · Open, Classified
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
  • Z-1806-2025 · Mar 18, 2025 · Open, Classified
    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
  • Z-2444-2023 · Jul 24, 2023 · Open, Classified
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
  • Z-2443-2023 · Jul 24, 2023 · Open, Classified
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
  • 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

Other NAIL, FIXATION, BONE devices

All NAIL, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.