TRIGEN 71647336Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010500922), received between Jul 24, 2023 and Jul 24, 2023 — classified as 1 malfunction.

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

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K040462, 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.

Recalls naming this device

1. Jul 24, 2023Open, Classified

   A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

   Z-2444-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Jul 24, 2023Open, Classified

   A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

   Z-2443-2023 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJul 24, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, WHILE INSTALLING THE 11.5 X 36 130 D TAN LT LIME ON A TARGETER, IT WAS NOTICED IT HAD A DIFFERENT LENGTH THAN INDICATED BY THE LABELS. ACCORDING TO THE LABELS, THE NAIL WAS SUPPOSED TO BE 36 CM LONG AND IN FACT IT WAS 40 CM LONG. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IMPLANTING A S+N BACK-UP NAIL, IN THE ORIGINAL HOLE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381007 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040462, 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