Device product
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Z-0588-2024
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 93507
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0588-2024
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) 350-41-23, GTIN none, Serial Numbers: A658148; b) 350-42-03, GTIN none, Serial Numbers: A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882
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
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.