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).
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: 826 units Lot/code info: a) Item Number 320-36-10, UDI/DI 10885862086631, Serial Numbers: 2608259, 2878175, 3759662, 3759663, 3810144, 3810149, 3786337, 3872525, 3872529, 3872524, 3872528, 3872526, 3872520, 3872535, 3872523, 3872539, 3872521, 3872534, 3872533, 3872537, 3872522, 2608258, 3872538, 3872536, 4124979, 4124982, 4124983, 4124978, 4291229, 4291226, 2878177, 4291213, 4124977, 4291230, 5027717, 3786334, 3872527, 4888837, 4888833, 5027713, 4988489, 4988487, 5027718, 4888828, 5165724, 5165727, 5165729, 4291218, 4291227, 3872531, 4291221, 4291228, 4291234, 4291225, 4291220, 5027706, 5027712, 5165730, 4696503, 4794697, 4696499, 4794698, 5165725, 4794699, 5869637, 5874634, 5869433, 5874635, 5869631, 5874638, 5869472, 5874626, 5909270, 5869429, 5869638, 5869450, 6167632, 5909268, 5869418, 5869422, 5909261, 5909266, 4291209, 4291231, 4794696, 5165722, 4988486, 4888836, 5869629, 6105291, 5869630, 6167625, 6023991, 6167650, 5869439, 6167646, 6522758, 6167637, 6190136, 6105269, 5869425, 6105281, 6064916, 6049281, 6167628, 6167644, 6190164, 6411847, 6190200, 6190139, 6049285, 6064914, 6008302, 5869475, 6044055, 6064921, 6064918, 6190229, 6167627, 6167652, 6190176, 6044060, 6190216, 5909259, 6105292, 6190171, 6522745, 5874639, 6553343, 6553295, 6593394, 6418061, 4988494, 4988493, 5869463, 6522759, 6008270, 6008278, 6522764, 6167648, 6167653, 6167630, 6044056, 5869443, 6008301, 6190135, 6008265, 6064908, 6008276, 5869437, 6483972, 6522742, 6167643, 6167611, 6008287, 6522768, 6023885, 6483986, 6008291, 6411
10885862086631, 10885862086648
Official record: FDA (Device enforcement) ↗
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