Medical Device Recall: Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Exactech, Inc. · March 6, 2024
Reason for Recall
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).
Distribution
Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
States Affected
NATIONWIDE
Quantity Affected
447 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1421-2024
Status: ongoing
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