Recall Z-0587-2024 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Exactech, Inc.
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
| Date | Jan 18, 2024 (initiated Nov 21, 2023) |
| Status | Open, Classified |
| Reason | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| Root cause | Packaging change control |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152217 | Exactech Vantage Total Ankle System Exactech, Inc., Mar 10, 2016 |