Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
This recall is currently active, issued January 18, 2024. It was issued by Exactech, Inc..
- Company
- Exactech, Inc.
- Recall Initiated
- November 21, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0587-2024
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Distribution
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
Lot / Code Info
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
Root Cause
Packaging change control
Action Taken
Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.