Recall Z-0024-2022— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2021-08-30. It names one FDA 510(k) clearance: K152217. Product: Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.. Reason: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-30
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Reason for recall
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.