Z-0588-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
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
Code Information
a) 350-41-23, GTIN none, Serial Numbers: A658148; b) 350-42-03, GTIN none, Serial Numbers: A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882