Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Exactech Equinoxe REVERSE SHOULDER Recalled by Exactech, Inc. Due to The packaging of these affected UHMWPE humeral liners...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.
Affected Products
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Quantity: 826 units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report