TRIGEN 71642695Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556132968), received between Nov 7, 2021 and Jan 4, 2022 — classified as 2 injuries.

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.

• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TRAUMA SURGERY HAD BEEN PERFORMED ON 2019, THE PATIENT EXPERIENCED A NON-UNION OF A SUBTROCANTHERIC FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY PERFORM ON (B)(6) 2021, IN WHICH THE META-TAN 10MM X 36CM RIGHT, AND THE SET OF SCREWS: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM, TRIGEN LOW PROFILE SCREW 5.0MM X 45MM AND META-TAN LAG/COMP KIT 95/90 WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. IT IS SUSPECTED THAT PATIENT HAS A BONE DISEASE BECAUSE SHE HAS A COUPLE OF FRACTURES CAUSED BY LOW ENERGY FORCES.

  Patient problems: Failure of Implant

  MAUDE report 13152524 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A METATAN 95/90 SCREW KIT WAS IMPLANTED INSTEAD OF AN INTERTAN 95/90 SCREW KIT. THIS WAS NOTICED AFTER OBSERVING THE X-RAY. IT IS UNKNOWN IF THE REMOVAL OF THE METATAN 95/90 SCREW KIT IS PLANNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756131 ↗

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