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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)

22

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 701–720 of 3680 recalls

Scorpio Total Knee Patella (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Left Small PCA Mod Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Tibial Bearing Insert (Howmedica) – Material Oxidation Risk (2023)

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.

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Moderate

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Left X-Large PCA Mod Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Right Large PCA Mod Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Trident Poly Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Dur PCA MTK Rev Insert Left (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

P7 32mm Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

P7 28mm Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Scorpio-Flex Total Knee Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Primary Rev Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

PS Lipped Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Link Patella Glide Guide (Waldemar Link) – Mislabeled Dimensions (2023)

Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

FDANov 30, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

GammaPod Treatment System (Xcision) – Planning Software Error (2023)

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

FDANov 30, 2023Nationwide• Xcision Medical Systems, LLC

Cardiac Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Anesthesia Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Leica HistoCore PEGASUS (Leica) – Tissue Processing Issue (2023)

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

FDANov 20, 2023Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

V. Mueller Bandage Scissors (Steris) – Color Residue Issue (2023)

Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing.

FDANov 16, 2023Nationwide• Steris Corporation

X-ray System (Canon) – Detector Image Abnormality (2023)

VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

FDANov 15, 2023CA, LA• Canon Medical System, USA, INC.

INFX-8000F (Canon) – Detector Image Abnormality (2023)

VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.

FDANov 15, 2023CA, LA• Canon Medical System, USA, INC.