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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

252

Past Year

2

Class I (Serious)

0

Most Recent

Nov 2025

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 1–20 of 252 recalls

The Stryker CranialMask Tracker is a single-use device co... (Howmedica Osteonics Corp.) – when the device is activated during s... (2025)

When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

FDANov 12, 2025Nationwide• Howmedica Osteonics Corp.

Exeter V40 Stem (Howmedica) – Product Mix Concern (2025)

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

FDAAug 28, 2025IN• Howmedica Osteonics Corp.

Triathlon Universal Baseplate (Howmedica) – Locking Tabs Issue (2024)

Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

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High

FDASep 4, 2024Nationwide• Howmedica Osteonics Corp.

MAKO Cutting System Handpiece (Howmedica) - Characterization Process Issue (2024)

Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.

FDAAug 7, 2024Nationwide• Howmedica Osteonics Corp.

Custom GMRS Extension Piece (Howmedica) – Design Mismatch (2024)

A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

FDAAug 5, 2024Nationwide• Howmedica Osteonics Corp.

UNITRAX Endoprosthesis Head (Howmedica) – Mislabeling Issue (2024)

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

FDAJun 19, 2024Nationwide• Howmedica Osteonics Corp.

Gray Revision Instrument Tray (Howmedica) – Case Design Issue (2024)

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

HRIS Storage Tray (Howmedica) – Case Design Problem (2024)

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

Trident II PSL Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER48D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL 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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Trident II Hemi Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL CLUSTER52E (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL CLUSTER64H (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII PSL 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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER52E (Howmedica Osteonics) – Excessive Shell Deburring (2024)

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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

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

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

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

FDAFeb 27, 2024Nationwide• 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

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.