Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, 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 SHOULDER46mmConstrained Humeral Linera) +0mmItem number 320-46-10b) +2.5mmItem Number 320-46-13Shoulder Arthroplasty
- Lot codes and dates
a) Item number 320-46-10UDI/DI 10885862086754
- Serial Numbers
251 of 251 codes
098453609845330984546101808910180951018091101809710180840984530098454709845290984532133274213613901545622154562413613881466508146651014665131466514146912714665111469130168355116835201683540168354116835451683548168355216835541683557168351513327371469126201072716835141683532168352916835362118729211873121042632118733211873209845351332736136139216835272010723168355820107211683523168352821945972265086229624722962492104265
- Serial Numbers
342 of 342 codes
098344309834120983426098342309834301069733106975210697811069734098343409834171069736106973509834250983442098342710697570983414098341909834351069761106977310697381069740106974714907591490757149076214907531546325106977010697671490755154632215463231546326180219716868101802204180290116868061686816168682118022001802902180290418021981686811180219610697761069765098343610697771490758199010319178442027971193980318022012027968
- Amount recalled
- 591 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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.