Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, 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 CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with
4 of 4 products
| Model / number | Product as published |
|---|---|
314-13-32 | 38, 41, 44, 47 head, Small |
314-13-33 | 41, 44, 47, 50, head, Medium |
314-13-34 | 44, 47, 50, 53 head, Large |
314-13-35 | 44, 47, 50, 53 head, Extra Large, ; Shoulder Arthroplasty |
- Lot codes and dates
a) Item Number 314-13-32UDI/DI 10885862201003
- Serial Numbers
506 of 506 codes
386465438646594140193415569042571794250984415567941402174155678386465841086794155704425718642571983926702410867642571944108680392670341556923864663386466238646533926698425717441086854269883415568342571734108681426988542698684155685415567742698704155700410868241086834269898415569741401984257180425719642698764968395468434846843554684340468435448080764808075496838947571154684353475712348080794968386506750948080724808060
- Serial Numbers
1,756 of 1,756 codes
386464638646363864645402429841552864087937414023141672173848609384861041004224108690410042141552834108697415528441004253864638402429638646443864643410869341552813848611386464038646414087940408793838486124108698392668539266803926682425100141402413926683422436542163534100424414023541553414155338432289143228944155357415527142243664269829410869541553344216350426981745202494251023433989042509934251024410869242163514155273
- Serial Numbers
1,342 of 1,342 codes
386462538646263926721402430040879334108661413962941553264155327410865138486043848605417113838646223926718402430438646344087936386463240242993848603386462338646333848606410041841004204139611427525438646204024303427524642752514551963415538442821034275257413961841599094139606413962341599084282064455197241004194275265428214842821294155317415539541553194282107428209142820674275256428212641553234155393413962538646244155316
- Amount recalled
- 4007 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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