Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
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 Equinoxe Humeral LinerItem
- Numbers
a) 320-40-00b) 320-40-03Shoulder Arthroplasty
- Lot codes and dates
a) 320-40-00UDI/DI 10885862535030
- Serial Numbers
1,976 of 1,976 codes
617342958675736007454600747859275876008225600752059275625927516592757561973316196344586755059275866196429587644461968335867568617455959276405927642600746761734325927563587644160074525876427592763161963595867564592758458764505927635600745659275696007567619642561967736173418586756561963556173443619676961967766196770600822660075146196351619636658764335876423619650561745545867558592752161964245927565592759161734366007475
- Serial Numbers
832 of 832 codes
591001359105446176692616822159333755932710591054061766896176705593270059105466170253616823961682426168231591003061766865910541593335159100115932804617668459327965932716593339159327015932782593340161766885932793593264561682455910015616824961682515933381591002159327175910023617022561682306168402591003359100185933356593336061682286168243616826161682676170227617666661683806168409616841164134976397898591055159327896168224
- Amount recalled
- 2806 units
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
This product could cause temporary or reversible health problems — stop using it.
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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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