Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, 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 Constrained Humeral LinerItem
- Numbers
a) 320-40-10b) 320-40-13Shoulder Arthroplasty
- Lot codes and dates
a) 320-40-10UDI/DI 10885862535054
- Serial Numbers
213 of 213 codes
593724259106915937233593684860620405936849619766261976726197682619768061976836197674641342360621076200990604684861970066062047591011064133796198008619700459369026484655593721961976765936834653356961976605936882653359059101206046849604683660620396046843604684764133766533602653360365336056533593653359565335966197026648465264846546484665648467261980146646211591069059369066198016604685259372485937208653342159368736533292
- Serial Numbers
236 of 236 codes
595837561675985958397595837659580196040054586966060072065958036600720460400386040041625279762528086008371605304860400576052792600721560072656484864625993060083656167606595839560083545958023605304260072135958035625991460469496046945617026762528006046941625992465339396533942648486364848676484874648489565339456533946657511865751406575136657515365751676008367625280465281116046567652809660072435958043600726259583776528124
- Amount recalled
- 447 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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