Exactech, Inc. 2024-04-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1409-2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY,… Recall
Issued April 10, 2024 · Exactech, Inc.
In April 2024, Exactech, Inc. recalled the Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Exactech, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Exactech, Inc.
- Category
- Health
- Recall date
- April 10, 2024
- Units affected
- Not reported
- Sold at
- Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, Indi
- Recall number
- FDA-Z-1409-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Exactech, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.