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: 35 units Lot/code info: a) Item Number 314-04-22, UDI/DI 10885862199553, Serial Numbers: 2111946, 2136867, 2136870, 2427405; b) Item Number 314-04-23, UDI/DI 10885862199560, Serial Numbers: 2111953, 2111954, 2139294, 2111955, 2139292, 2139291, 2139288, 2139290, 2424307, 2424304, 2111952, 2424306, 2424314, 2424305, 2482942; c) Item Number 314-04-24, UDI/DI 10885862199577, Serial Numbers: 2111949, 2111950, 2153613, 2153608, 2153607, 2153611, 2153612, 2421997, 2153609, 2421992, 2111951, 2153610, 2421994; d) Item Number 314-04-25, UDI/DI 10885862199584, Serial Numbers: 2112018, 2112019, 2427567
10885862199553, 10885862199560, 10885862199577, 10885862199584
Official record: FDA (Device enforcement) ↗
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