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TRIGEN 71642305Recalls & reported problems

Smith & Nephew, Inc. · TRIGEN INTERNAL HEX CAPTURED RECON SCREW BLUE 6.4MM X 105MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010516640), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

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.

  • InjuryJun 28, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT, DURING AN OSTEOSYNTHESIS FRACTURE SURGERY, A INT HEX RC SCR BL 6.4X105 WAS OUTSIDE THE FEMORAL HEAD. SURGERY WAS RESUMED, AFTER A 30MIN OR MORE DELAY, WITH A BACKUP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12076309 ↗

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-2443-2023 · Jul 24, 2023 · Open, Classified
    TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
  • 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-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.