Reported Dec 27, 2023 · Ongoing
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Exactech Vantage Ankle System
- Catalog Numbers
a) 350-21-04b) 350-22-03
- Lot codes and dates
a) 350-21-04GTIN 10885862276247
- Serial Numbers
A644020b) 350-22-03GTIN 10885862276353
- Serial Numbers
A641653A641655A641659A641660A641662A641663A641666A641667A641668A641669A641672A641654
- Amount recalled
- N/A
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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