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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.

Moderate

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.

Moderate

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

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

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

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

Series II Tibial Bear Insert (Howmedica) – Material Oxidation Risk (2023)

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

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

Scorpio NRG Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

Duration A-P Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

Scorpio Recessed Patella (Howmedica) – Material Oxidation Risk (2023)

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

Scorpio U-Dome Patella (Howmedica) – Material Oxidation Risk (2023)

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

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

Omnipod 5 App (Unknown) – Bolus Calculator Error (2023)

BrightView Gamma Camera (Philips) – Scan Motion Gap (2023)

BrightView X Camera (Philips) – Scan Motion Gap (2023)

Spectral CT 7500 (Philips) – Software Functionality (2023)

BrightView XCT (Philips) – Scan Motion Gap (2023)

Dressing Change Tray (Busse) – Saline Lot Recall (2023)

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