Fusion Nail 15-0028/07Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026575175215), received between Nov 8, 2023 and Feb 6, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

16 other recalls cover devices cleared under the same FDA submission (K151008); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Component Missing

  WE HAVE BEEN INFORMED THAT THERE WAS AN ISSUE WITH THE SCREWS PACKAGED WITH THE ENDO MODEL FUSION NAIL. THE COMPLAINANT STATED THAT 2 LOTS OF THE FUSION NAIL WERE OPENED AND DID NOT HAVE PRE-LOADED SCREWS IN THE TRUNNION. EACH PACKAGE ONLY CONTAINED 4 "FLAT" SECONDARY SCREWS IN A SEPARATE PACKAGE. LOT 2545069 WAS OPENED FIRST, THEN LOT 2535246 WAS OPENED BUT THEY WERE THE SAME - NO PRE-LOADED SCREWS, ONLY 4 SECONDARY SCREWS. LOT 2535246 WAS IMPLANTED WITH NO ISSUE REPORTED AFTER USING THE SECONDARY SCREWS IN THE PROCEDURE. [CUSTOMER]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275946 ↗
• MalfunctionFeb 6, 2026Component Missing

  WE HAVE BEEN INFORMED THAT THERE WAS AN ISSUE WITH THE SCREWS PACKAGED WITH THE ENDO MODEL FUSION NAIL. THE COMPLAINANT STATED THAT 2 LOTS OF THE THE FUSION NAIL WERE OPENED AND DID NOT HAVE PRE-LOADED SCREWS IN THE TRUNNION. EACH PACKAGE ONLY CONTAINED 4 "FLAT" SECONDARY SCREWS IN A SEPARATE PACKAGE. LOT 2545069 WAS OPENED FIRST, THEN LOT 2535246 WAS OPENED BUT THEY WERE THE SAME - NO PRE-LOADED SCREWS, ONLY 4 SECONDARY SCREWS. LOT 2535246 WAS IMPLANTED WITH NO ISSUE REPORTED AFTER USING THE SECONDARY SCREWS IN THE PROCEDURE. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275945 ↗
• MalfunctionNov 3, 2025Component Misassembled; Component Misassembled

  REPORTED BY CUSTOMER ON (B)(6) 2024, THAT A FUSION WAS BEING IMPLANTED AND FOUND THAT ONE SCREW IN THE TRUNNION ON THE FEMORAL COMPONENT WAS IN BACKWARDS. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY AS THE SCREW WAS BACKED OUT AND USED AND THE PROCEDURE CONTINUED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448476 ↗
• InjuryNov 15, 2023Misassembled; Detachment of Device or Device Component; Misassembly by Users; Misassembled; Detachment of Device or Device Component; Misassembly by Users

  REPRESENTATIVE S. REPORTED THAT THE DOCTORS OFFICE REACHED OUT TO THE REPS OFFICE INQUIRING THE AVAILABILITY OF ANOTHER FUSION NAIL TO PERFORM THE REVISION SURGERY ON (B)(6) 2023. ADDITIONAL INFORMATION AND THE EXPLANTED DEVICE HAS BEEN REQUESTED FOLLOWING THE REVISION SURGERY, WITH DR. M. [CUSTOMER]

  Patient problems: Failure of Implant

  MAUDE report 18139558 ↗
• InjuryNov 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REPORTED TO LINKBIO ON (B)(6) 2023 REGARDING A FAILURE OF A MODULAR FUSION NAIL, WITH DR.M. ORIGINALLY IMPLANTED (B)(6) 2019 FOR REVISION SURGERY ON (B)(6) 2023. IT APPEARED THAT THE IMPLANT BEING REVISED WAS IMPLANTED BACKWARDS. THE SCREWS ARE NOT RECESSED ALL THE WAY, AS THEY WERE INSERTED IN THE WRONG SIDE OF THE TIBIA COMPONENT. REVISION SURGERY WAS REPORTED TO BE VERY SUCCESSFUL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18095061 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151008. One submission often covers many models, so check the product and lot details in each record.

• Z-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-0890-2026 · Nov 10, 2025 · Open, Classified
  Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
• Z-2411-2024 · May 22, 2024 · Open, Classified
  Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75m

…and 1 more.