Exactech, Inc.: Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

Hazard

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).

Details from the source

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 Quantity: 2806 units Lot/code info: a) 320-40-00, UDI/DI 10885862535030, Serial Numbers: 6173429, 5867573, 6007454, 6007478, 5927587, 6008225, 6007520, 5927562, 5927516, 5927575, 6197331, 6196344, 5867550, 5927586, 6196429, 5876444, 6196833, 5867568, 6174559, 5927640, 5927642, 6007467, 6173432, 5927563, 5876441, 6007452, 5876427, 5927631, 6196359, 5867564, 5927584, 5876450, 5927635, 6007456, 5927569, 6007567, 6196425, 6196773, 6173418, 5867565, 6196355, 6173443, 6196769, 6196776, 6196770, 6008226, 6007514, 6196351, 6196366, 5876433, 5876423, 6196505, 6174554, 5867558, 5927521, 6196424, 5927565, 5927591, 6173436, 6007475, 6007480, 6174553, 6008237, 6008243, 6196419, 6007548, 5927483, 6008351, 6174566, 5927485, 6196445, 6196433, 5867562, 5867567, 5876432, 5927498, 5876437, 5867556, 5927608, 5876430, 5876451, 5927561, 6008344, 6007543, 5927510, 6196364, 6196530, 6007568, 6196525, 6173428, 6196357, 5867557, 6196422, 6174552, 5876434, 5927543, 6173442, 6173434, 5927564, 6007465, 6196517, 5927530, 5927532, 6008346, 6196353, 6196349, 5927573, 5927492, 5927547, 6007571, 6196365, 6173445, 5876440, 5867563, 6007479, 6196764, 5867561, 6174557, 6196352, 6008348, 6196439, 5927639, 5927632, 6173430, 6008347, 6008343, 6008240, 6173435, 5927522, 6196427, 5927515, 5927592, 5927589, 6196760, 5927488, 6174573, 6173426, 6008341, 6007519, 5867553, 5927524, 6196348, 5876436, 5876428, 5927518, 6007466, 5876446, 5927497, 6174565, 5927538, 5927576, 5927596, 5876435, 5876439, 5876445, 5876448, 5927512, 5927519, 5927619, 5927622, 5927623

UPC codes

10885862535030, 10885862535047

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.