TRIGEN 71642675Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556133002), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6)2021. THE SURGEON DETERMINED THIS FAILURE WAS DUE TO A NON-UNION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12537576 ↗

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