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Recall Observatory FDA recall evidence

Device product

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

Z-0583-2024

November 21, 2023

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 93507
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0583-2024

Official wording

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

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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