Recall Z-0588-2024— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2023-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03. Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-21
- Firm location
- Gainesville, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.