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Exactech Equinoxe Cage Glenoid (Exactech) – Packaging Nonconformance (2024)

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)

High

FDAMar 6, 2024Nationwide• Exactech, Inc.

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Exactech Equinoxe Cage Glenoid (Exactech) – Packaging Nonconformance (2024)

Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)

Exactech Equinoxe Humeral Liner (Exactech) – Packaging Nonconformance (2024)

Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)

Tablo Hemodialysis System (Outset Medical) – Tubing Replacement (2024)

Exactech Equinoxe Reverse Shoulder Liner (Exactech) – Packaging Nonconformance (2024)

Exactech Equinoxe Humeral Liner (Exactech) – Packaging Nonconformance (2024)

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