Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, 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 CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with
4 of 4 products
| Model / number | Product as published |
|---|---|
314-13-22 | 38, 41, 44, 47 head, Small |
314-13-23 | 41, 44, 47, 50, head, Medium |
314-13-24 | 44, 47, 50, 53 head, Large |
314-13-25 | 44, 47, 50, 53 head, Extra Large, ; Shoulder Arthroplasty |
- Lot codes and dates
a) Item Number 314-13-22UDI/DI 10885862196163
- Serial Numbers
520 of 520 codes
386457541085943864576392668741728924155858412246641728964108598410859741225084257141412247738645713926691412252938645694268100386458041085894122492412245941225174268102412249738645794268113426812041085933926690425716241225164268088386456842681074257139412250442681084257145417289950833964967722496772547569774730330485476247303314854749496773247303335077524386458141225253864572412247541225234268112410859941224674122496
- Serial Numbers
1,523 of 1,523 codes
418293638645674122604390150239266933901509392669239015044108606415585541086074122639417114138645544108604412259041225953864563386456638645533926697392669539014943926694390150739015014122588390151038645554108610425709241829464257079386456242682084268173452801141226224257082418293841605804122591433989841711404155852425064442681954182937425709442681744182942412260843398994257061412262342506274122602452802541226183864556
- Serial Numbers
1,237 of 1,237 codes
386459438646004024294402429340418614108623412178239267063864602386460140242954041860416072038645914087946386460438498793926709386459541218393926708408794841086223926705386459741218214108624416721641607194257096426823941218294208662420865941217734155845412177241218254250652410861941402723864592420866142086604087949425067238645934121768412181542506584250659412182442682214121808423237142506794257129425067742571254208658
- Serial Numbers
162 of 162 codes
384988138646774122170384988239485534122154412214941221364108757412212742636953864670412216842637104263653394855141221123948560426366242636864263707485495341221134108760386466742637254263709426369342637213948556412213941221584263733426371347665865318544476658547570905539392516352049827984122125426366142636984122134412213042637204122144386466942637304263649412212238646785318531498279951635195318522516351153185275082472
- Amount recalled
- 3436 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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