Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, 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, RIGHT, Mates with
4 of 4 products
| Model / number | Product as published |
|---|---|
314-02-32 | 38, 41, 44, 47 head, Small |
314-02-33 | 41, 44, 47, 50 head, Medium |
314-02-34 | 44, 47, 50, 53 head, Large |
314-02-35 | 44, 47, 50, 53 head, Extra Large, ; Shoulder Arthroplasty |
- Lot codes and dates
a) Item Number 314-02-32UDI/DI 10885862175052
- Serial Numbers
140 of 140 codes
209067019843702086996209065521086712086997208699923794242479807264037421426822147846214267924797982090659214785721478472640379209066520869832640371214267521478342086981264040620869981984369214785326403971984379262833426403772640375264038427524303570463357047426403722142674198437823794262640380264039126403942640395264040326404102379418259487626403853616755361675937583733616754357047329835743570462357046135704541984381
- Serial Numbers
403 of 403 codes
208492719850292084773214120219850361985027208478120847882084783198502020849042084930198502419850312084771208476323794482084766208492020847742084772242611820847792084916198502821412002084914214980519850332485893208491921498032149820210574619850301985021208476421498232149828214980019850321985026210574521498102379454237946624260972149824248588424264462084922237946521498112426423242644720847772149788214980924264272379453
- Serial Numbers
382 of 382 codes
198479819848061984812198480320935042150262215026119847991984801208343620934811984797198480019848022083426208343021502682093474229311122931012425166198480520834502083469242515720834642083432209351520934832093516242518021502702093513208345922931042150265208344120834452093505209347220834552083460198480924829312425152208344619848102093491208343720834432083440229310921502712150264209349720934872093482209350624251622425170
- Serial Numbers
66 of 66 codes
208487419850931985091208487919850971985106198510420848591985102198509421697271985095213872421387022640472216972520848952084896237803223780232378019216972623780212084882208485735715512961483275246319850962640480237802621386992640495237803024798411985100275245745238044442573535916244425774442570528014654573215457335595797059579885957990587519658751865359158513352844425754466032545733353591536713270452380651432895359164
- Amount recalled
- 985 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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