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Howmedica Osteonics Corp.

Howmedica Osteonics Corp. Recalls

All product recalls associated with Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 641–660 of 3680 recalls

TRIDENTII HEMI CLUSTER44B (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER50D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER66H (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDA

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Page 33 of 184Next

Feb 27, 2024

Nationwide

• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER58F (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Cardiovascular Procedure Kits (Terumo) – Pressure Valve Issue (2024)

Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention

High

FDAFeb 20, 2024Nationwide• Terumo Cardiovascular Systems Corporation

CARTO VIZIGO Sheath (Biosense Webster) – Manufacturing Mix-Up (2024)

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

Moderate

FDAFeb 16, 2024Nationwide• Biosense Webster, Inc.

Western Star 49X (Western Star) – Suspension Hanger Failure (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2022-2024 Western Star 49X vehicles. The suspension hanger may fail due to missing welds, which can result in difficulty steering and maintaining the direction of the front two wheels.

Moderate

NHTSAFeb 8, 2024Nationwide• WESTERN STAR

DLP Vessel Cannula (Medtronic) – Labeling Error (2024)

Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

Low

FDAFeb 7, 2024GA• Medtronic Perfusion Systems

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

Azurion 3 (Philips) – Generator Failure Risk (2024)

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

High

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

Azurion 5 (Philips) – Generator Failure Risk (2024)

High

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SPII Lubinus Prosthesis (Waldemar Link) – Labeling Confusion (2024)

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Low

FDAFeb 6, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

Triathlon TS Plus Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

Azurion 7 (Philips) – Generator Failure Risk (2024)

High

FDAFeb 6, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Triathlon TS Plus Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

Moderate

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

SPII Lubinus Hip Prosthesis (Waldemar Link) – Labeling Confusion (2024)

Low

FDAFeb 6, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Western Star 49X (Western Star) – ESC Malfunction (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2024-2025 Western Star 49X and 2025 Freightliner Cascadia vehicles. The Electronic Stability Control (ESC) software has incorrect axle spacing parameters. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 136, "Electronic Stability Control Systems on Heavy Vehicles."

High

NHTSAJan 31, 2024Nationwide• WESTERN STAR