Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GX

Hazard

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Details from the source

Reason for recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN Quantity: 3793 devices Lot/code info: a. 130-28-50, GUDID 10885862022059, Serial Numbers: 1784995, 1784996, 1784998, 1785000, 1785002, 1785003, 1785006, 1785011, 1785012, 1785013, 1785015, 1785016, 1785017, 1785018, 1785022, 1785024, 1785026, 1785027, 1785030, 1785032, 1785033, 1796637, 1796640, 1796641, 1796642, 1796644, 1796647, 1796652, 1796654, 1796655, 1796656, 1796658, 1810811, 1810813, 1810814, 1810818, 1810819, 1810821, 1810822, 1810825, 1810828, 1810829, 1810831, 1810832, 1859562, 2540144, 2540145, 2540146, 2540147, 2540148, 2540150, 2633432, 2633433, 2691744, 2691746, 2691747, 2691748, 2691749, 2691750, 2691751, 2691752, 2707045, 2707047, 2707048, 2707049, 2707050, 2800307, 2800308, 2812276, 2812277, 2893670, 2893671, 2893672, 2976865, 2976866, 2976867, 2976868, 2976869, 3544420, 3544421, 3544422, 3544423, 3544424, 3544431, 3544432, 3544435, 3544437, 3544439, 3544442, 3544444, 3544445, 3544446, 3544447, 3544450, 3673569, 3673571, 3673572, 3673573, 3673574, 3673575, 3673577, 3673578, 3673579, 3673581, 3673583, 3673586, 3673587, 3673588, 3673589, 3673592, 3673593, 3673594, 3673595, 3673596, 3673597, 3673598, 3673599, 3673600, 3712228, 3712229, 3712230, 3712231, 3712232, 3712234, 3712236, 3712238, 3712239, 3712241, 3712455, 3712457, 3712458, 3712459, 3712460, 3712462, 3712463, 3744701, 3744702, 3744703, 3744704, 3744705, 3744706, 3744707, 3744708, 3744710, 3744713, 3744714, 3744715, 3744716, 3744717, 3744718, 3744720, 3744722, 3744723, 3744724, 3978806, 3978807, 3978808, 3978810, 3978811, 3978815, 3978817,

UPC codes

10885862022059, 10885862021892, 10885862023148

Source

Official record: FDA (Device enforcement) ↗

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