Fusion NailRecalls & reported problems across all models

We found 2 models of Fusion Nail by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2023 and Feb 6, 2026 — classified as 2 injuries, 4 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fusion Nail recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 10, 2025Class IIOpen, Classified

   The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

   Z-0890-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Fusion Nail problems

Fusion Nail models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fusion Nail 15-0028/08

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
  1 recall1 report
• Fusion Nail 15-0028/07

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
  5 reports

Recent Fusion Nail adverse event reports

The 6 most recent reports across all models, 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 ↗
• MalfunctionOct 30, 2025Component Misassembled; Component Misassembled

  "NOTIFIED THAT DURING A FUSION NAIL CASE, THE RESIDENT WAS UNABLE TO ADVANCE THE SET SCREW. ANOTHER BOX WAS OPENED AND USED WITH NO ISSUE. THE REPRESENTATIVE STATED THAT WHILE THE CEMENT WAS HARDENING IN A FUSION NAIL CASE, THE MORSE TAPER WAS IMPACTED. THEN THEY WENT TO ENGAGE THE SET SCREW BUT THEY WERE NOT ABLE TO ADVANCE IT. IN ORDER TO SAVE TIME, A NEW IMPLANT WAS OPENED AND USED WITHOUT ISSUE. THE DELAY WAS LESS THAN 4 MINUTES. UPON INVESTIGATING THE WASTED IMPLANT LATER, THE REPRESENTATIVE FOUND THE SCREW IN THE MORSE TAPER WAS ASSEMBLED BACKWARDS. THE PART WILL BE RETURNED FOR THE INVESTIGATION." [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424135 ↗
• 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 ↗

Other WALDEMAR LINK GmbH & Co. KG products

• Unicondylar Sled Prosthesis48 models · 12 reports · 48 recalls
• Endo-Model Modular Knee Prosthesis System64 models · 57 reports · 12 recalls
• LinkSymphoKnee117 models · 79 reports · 11 recalls
• LINK Instrument14 models · 8 reports · 12 recalls
• Endo-Model SL Knee Prosthesis System25 models · 52 reports · 6 recalls
• Endo-Model Standard Knee Prosthesis System15 models · 19 reports · 6 recalls
• LINK Embrace Shoulder System Line Extension2 models · 1 reports · 4 recalls
• SPII Model Lubinus174 models · 6 reports · 3 recalls