TRIGEN 71701125LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010543202), received between Jun 28, 2017 and Nov 27, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

11 other recalls cover devices cleared under the same FDA submission (K043052, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2017Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT BOTH DISTAL SCREWS BACKED OUT OF THE NAIL AND HAD TO BE SURGICALLY REMOVED. SCREW WAS REMOVED COUPLE OF MONTHS FOLLOWING IMPLANTATION WHILE THE NAIL REMAINED IMPLANTED.

  Patient problems: No Information

  MAUDE report 7058468 ↗
• InjuryNov 27, 2017Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT BOTH DISTAL SCREWS BACKED OUT OF THE NAIL AND HAD TO BE SURGICALLY REMOVED. SCREW WAS REMOVED COUPLE OF MONTHS FOLLOWING IMPLANTATION WHILE THE NAIL REMAINED IMPLANTED.

  Patient problems: No Information

  MAUDE report 7058463 ↗
• InjuryNov 27, 2017Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT BOTH DISTAL SCREWS BACKED OUT OF THE NAIL AND HAD TO BE SURGICALLY REMOVED. SCREW WAS REMOVED COUPLE OF MONTHS FOLLOWING IMPLANTATION WHILE THE NAIL REMAINED IMPLANTED.

  Patient problems: No Information

  MAUDE report 7058462 ↗
• InjuryJun 28, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE DISTAL SCREWS BACKED OUT OF THE NAIL AND HAD TO BE REMOVED. THE NAIL REMAINS IMPLANTED.

  Patient problems: Injury; No Information

  MAUDE report 6675312 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043052, 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
• Z-2083-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulati
• Z-2087-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulat
• Z-2088-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulat
• Z-2084-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulati
• Z-2085-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation
• Z-2086-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation
• Z-2082-2008 · Apr 22, 2008 · Terminated
  TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulation