Recall Z-0024-2022 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Exactech, Inc.
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.
| Date | Oct 4, 2021 (initiated Aug 30, 2021) |
| Status | Open, Classified |
| Reason | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. |
| Root cause | Process control |
| Action | Exactech notified distributors and sales representatives on about 08/30/2021 via letter titled "URGENT MEDICAL DEVICE RECALL." Actions included removing all Knee and Ankle UHMWPE products labeled with an 8-year shelf life and not packaged in EVOH/Nylon bags, in a phased approach over 12 months. Phase 1: immediately return all knee and ankle UHMWPE devices labeled with an 8-year shelf life that will be 5 years old or older by 08/31/2022 not packaged in EVOH/Nylon bags. Phase 2: between 05/31/2022 to 08/31/2022, returning all remaining knee and ankle UHMWPE devices labeled with an 8-year she |
| Quantity | 2,217 devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152217 | Exactech Vantage Total Ankle System Exactech, Inc., Mar 10, 2016 |