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Recall Observatory FDA recall evidence

Device product

Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

Z-0587-2024

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-0587-2024

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) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654

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.