RecallCheckr

Howmedica Osteonics Corp. recalls

12 recalls on record · FDA

Every recall we have on record for Howmedica Osteonics Corp., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Serious

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed…

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.

Howmedica Osteonics Corp. Dec 31, 2025
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Health Serious

Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient…

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

Howmedica Osteonics Corp. Sep 4, 2024
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Health Serious

TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk…

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

Howmedica Osteonics Corp. May 1, 2024
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Health Serious

TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high…

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

Howmedica Osteonics Corp. May 1, 2024
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Health Serious

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part…

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number:…

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product…

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement …

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product…

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement …

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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Health Serious

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement …

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Howmedica Osteonics Corp. Feb 7, 2024
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