Reported Oct 13, 2021 · Ongoing
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX,…
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?
- Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene
- Liner Component (Product Line
350-21-XX350-22-XX)b. Vantage Mobile-Bearing Polyethylene
- Liner Component (Product Line
350-41-XX350-42-XX)
- NOTEInformation reflects Exactech recall expansion initiated on 02/07/2022
- Lot codes and dates
- a. Item Number (Device Identifier
- Serial number(s))
1,626 of 1,626 codes
350-21-01 (1088586227621648337104833714483371548337174833723518800551880075188008518800951880115188013518801551880175188021518802251880235939820593982659398315939832593983359398355939836593983759398385939839593984059398415939842593984459398455939846601555360155546015556601555760155606015563601556660155676015569639648663964896396493639649563965006396504639650564893796489381648938264893846489386660665966066676606678686012668601276900582
- Serial number(s))
681 of 681 codes
350-41-01 (10885862276452485179748517984851799485180049641084986270519434851943505194353519435651943575194358640967065060016506009685764468576466857652)350-41-02 (1088586227646948501024850103485010448501054963948496395151942755194276519427751942795194280519428151942825194283519428551942865194287519428851942895194290519429151942925865068586507258650735865076586508158650865865087586508963307216330728633073265071806507186650719865922346592235)350-41-03 (108858622764764851814
- Amount recalled
- 2,217 devices
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.