TRIGEN 71642685Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556132982), received between May 12, 2021 and Sep 20, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FRACTURE IN THE LEFT FEMUR DUE TO A FALL. AN INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2024 DURING WHICH THE SURGEON INSERTED AN INTERTAN 11.5MM X 20CM 125D (71675205) WITH META-TAN LAG/COMP KIT 85/80 (71642685). AFTER THE SURGERY, AT THE VISIT TO THE CLINIC ON (B)(6) 2024, THE PATIENT COMPLAINED OF PAIN IN HER LEFT THIGH AND HIP JOINT. AN X-RAY REVEALED HARDWARE CUTOUT AND A FEMORAL FRACTURE AT THE BASE OF THE NECK. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE INTERTAN NAIL AND META-TAN SCREWS AND CONVERT TO A THR.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 20274596 ↗
• InjuryMay 12, 2021Device Markings/Labelling Problem; Unintended Movement; Device Markings/Labelling Problem; Unintended Movement

  IT WAS REPORTED THAT AFTER TRAUMA PROCEDURE FOR INTERNAL HIP FIXATION, THE PATIENT HAD POSTOPERATIVE PAIN ON THE HIP JOINT, COPD EXACERBATION AND LUNG INFECTION. X-RAY EXAMINATION INDICATED GOOD POSITIONING OF THE IMPLANT. TWO DAYS AFTER THE PROCEDURE, IT WAS DISCOVERED THAT TRIGEN META-TAN TROCH ANTEGR NAIL SCREWS WERE USE TO FIXATE A TRIGEN INTERTAN INTERTROCH ANTEGR NAIL, CAUSING THE IMPLANT TO BE UNSTABLE. A REVISION SURGERY HAD TO BE PERFORMED IN ORDER TO RETRIEVE THE WRONG SCREWS AND INSERT THE CORRECT ONES. DETAILS ABOUT THE SURGERY ARE UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Implant Pain; Respiratory Tract Infection

  MAUDE report 11815676 ↗

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