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Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, ...

FDA Recall #Z-0583-2024 — Class II — November 21, 2023

Recall #Z-0583-2024 Date: November 21, 2023 Classification: Class II Status: Ongoing

Product Description

Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

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

a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561

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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