Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with
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 GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with
4 of 4 products
| Model / number | Product as published |
|---|---|
314-02-22 | 38, 41, 44, 47 head, Small |
314-02-23 | 41, 44, 47, 50 head, Medium |
314-02-24 | 44, 47, 50, 53 head, Large |
314-02-25 | 44, 47, 50, 53 head, Extra Large, ; Shoulder Arthroplasty |
- Lot codes and dates
a) Item Number 314-02-22UDI/DI 10885862175052
- Serial Numbers
172 of 172 codes
198457619845752090821198457019845811984569209082420936112090832209082523790032090861209082019845772090843237899923790292425682237899820908542425684209363620908552093634242567619845732485867237901720908422640254264026226402552754817209361823790192090826264024126548912093613209362126548902485860242568920908632425683265488726283232640277295127829614862090862209085026402522640279265488826548922654894237902526402612754818
- Serial Numbers
324 of 324 codes
198415319841612093802209379220678261984166206781119841592067793206781621506152067802209377924260462150607215060219841632067809209377220678131984168242608920937832067822206780324260361984167209378820678351984154198416021506312067815206778920937642093773209380524260842093780209379924260652479772255924020678312479781209377824260472426082242606124260572479771215062720677972093765247976419841692426088255923920937892093793
- Serial Numbers
273 of 273 codes
198424620737221984239198424520737001984236207369620736941984241198424820949242073690209491820949082485852209492920949032146925207372820736921984242198425020737271984243209493520948912094920209491024274212073684214693024135302413532241354124135162413539248585724135442485854207368321469292427413263779924135172621366263778520737072094893248584324858452637776198424920737242073686263780519842442427412241350920737192413520
- Serial Numbers
198459419845951984596198459320867962147635248587526377532167696214761821476492419041214764421425203592854357153625915494555103452188349257284148695460744951634304572652452188255433954607452531992255434105543408531994659604135381658596042446074516872159492573353199195319942538166851634125960410
- Amount recalled
- 805 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.
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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