Exactech, Inc.: Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; 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: 11863 units Lot/code info: a) Item Number 320-36-00, UDI/DI 10885862086617, Serial Numbers: 1954421, 1954426, 1954423, 1954422, 1954424, 2084846, 2102178, 2095168, 2085991, 2142641, 2200474, 2200475, 2142642, 2223309, 2276145, 2399592, 2418172, 2418175, 2418174, 2399591, 2223310, 2223311, 2276143, 2276140, 1954425, 2276142, 2418173, 2276144, 2399593, 2399590, 2662625, 2528861, 2528862, 2528864, 3637099, 3673852, 3637100, 3637097, 2662624, 2788819, 2662626, 2788821, 3573735, 3573734, 3616397, 2565880, 2565882, 3616398, 3616399, 3616396, 3637096, 3694392, 2662627, 2823683, 3740075, 3754460, 3758537, 2200473, 2399594, 2276141, 3694390, 3740074, 3694391, 2565878, 3740073, 2823681, 2823684, 3918249, 3918248, 3989825, 3989840, 3827079, 3870844, 3918250, 3989838, 3870840, 3918260, 3870838, 3989830, 3989841, 3918261, 3827096, 3870834, 3870843, 3827084, 4028552, 3827081, 3827091, 3827095, 3827076, 3827094, 3827082, 3827078, 3827087, 3827088, 3827089, 3827097, 3827083, 3827090, 3827093, 3827080, 3918243, 3918247, 3918251, 3918254, 3918255, 3918242, 3918245, 3918252, 3918253, 3918258, 3918244, 3918246, 3918256, 3918257, 3918262, 3918263, 3989821, 3989822, 3989828, 3989833, 3989834, 3989842, 3989843, 3989846, 3870835, 3989835, 3989844, 3989824, 4028569, 4028574, 4028564, 4028565, 4028568, 4028551, 4028554, 4028557, 4028559, 4028560, 4028561, 4028562, 4028566, 4028567, 4028570, 4028571, 4028572, 4028573, 4028575, 4028576, 4028577, 4064490, 4064491, 4064492, 4064495, 3827077, 3827085, 3827086, 3827092, 3870837, 3870

UPC codes

10885862086617

Source

Official record: FDA (Device enforcement) ↗

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