Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item…
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 REVERSE SHOULDER42mm Constrained Humeral Linera) +0mmItem number 320-42-10b) +2.5mmItem Number 320-42-13Shoulder Arthroplasty
- Lot codes and dates
a) Item number 320-42-10UDI/DI 10885862086716
- Serial Numbers
1,811 of 1,811 codes
098289009829060982900098290110340661034062103406410340821034089103406710340681034078103409710715031071501103407910714940982898103407109828961034092107149109829141034087107146110715051071500098289109828941252956125297312529991252980125298310928371034077103408410714861034075107148809829151071473098289213801401252966139549214163911380144145771314577061416390146303412529621395487107147410715061071492107148210340721395489
- Serial Numbers
1,799 of 1,799 codes
098295209829490982938108557010855851085608108560910855741085578108559110856101085617109355710935581085569098294709829281085600108560610855961085598109355110855731085595109353909829220982950137978013053561305334130535010855821085579109353009829541085615109351910855681093562098292310935321093537098293110935101305331149875413797691305353146239013797811305335130535513053251379764130534014987661435555108558910855800982943
- Amount recalled
- 3648 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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