Fusion Nail 15-0028/08Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Fusion Nail, modular · Class 2 · Implant

All models of Fusion Nail (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575175222), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

15 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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

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 problems

Device problems

Component Misassembled1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

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-1516-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Z-1522-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Z-1512-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Z-1514-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Z-1513-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Z-1520-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Z-1515-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Z-1519-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Z-1521-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Z-1518-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Z-1511-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Z-1517-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Z-2410-2024 · May 22, 2024 · Open, Classified
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-281
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

Device details

UDI-DI	`04026575175222`
Brand	Fusion Nail
Model	15-0028/08
Company	WALDEMAR LINK GmbH & Co. KG
Product code	LWJ · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Class	Class 2
FDA submission	K151008
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 2, 2026

Device type (GMDN): Arthrodesis intramedullary nail, non-distracting

A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices

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166 reports
Trident 623-00-36E
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112 reports
Accolade 6021-0435
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88 reports
EXETER 0580-1-044
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
1 recall22 reports
Endo-Model SL Knee Prosthesis System 16-2840/02
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall17 reports
Endo-Model SL Knee Prosthesis System 16-2840/05
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall12 reports
Trident 623-10-36E
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
57 reports
LFIT 6260-9-336
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
56 reports

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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