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Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

FDA Recall #Z-0584-2024 — Class II — November 21, 2023

Recall #Z-0584-2024 Date: November 21, 2023 Classification: Class II Status: Ongoing

Product Description

Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

Reason for Recall

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Recalling Firm

Exactech, Inc. — Gainesville, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

Code Information

GTIN 10885862001924, Serial Numbers: A649282, A649289

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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