TRIGEN 71642605Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556133071), received between Jul 23, 2021 and Feb 5, 2025 — classified as 2 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K092748, K210980); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION WAS PERFORMED IN (B)(6) 2023, THE FRACTURE DYNAMIZED, LEAVING THE LAG SCREW PROUD OVER THE LATERAL FEMUR. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LAG SCREW WAS REMOVED AND A SHORTED SCREW WAS INSERTED. DURING THE REMOVAL PROCEDURE, THE HEAD OF THE LAG SCREW BROKE OFF. DRILLING ALONG THE INFERIOR LAG SCREW TRACT WAS PERFORMED TO REMOVE ANY RESIDUAL SURROUNDING BONE. THE SCREW WAS ULTIMATELY REMOVED WITH VICE GRIPS. PATIENT IS DOING WELL.

  Patient problems: Failure of Implant; Laceration(s)

  MAUDE report 21314195 ↗
• InjuryJul 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A INTRAMEDULLARY SURGERY ON (B)(6) 2021, A REVISION SURGERY WAS MADE ON (B)(6) 2021 BECAUSE AN INCORRECT METATAN INTERGRATED LAG WAS SCREWED INTO THE INTERTAN CONSTRUCT (BOXES BETWEEN INTERTAN & METATAN LAG SCREWS ARE ALMOST IDENTICAL TO LOOK AT). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K210980. 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