Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM

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: 58158 devices Lot/code info: a. REF 130-28-51, GUDID 10885862022066, Serial Numbers: 1018800, 1018801, 1018805, 1018806, 1018808, 1018809, 1018810, 1018814, 1018815, 1018816, 1018817, 1018818, 1018823, 1018824, 1018832, 1018834, 1018835, 1018836, 1018845, 1018848, 1018850, 1149854, 1149855, 1149861, 1149863, 1149865, 1149866, 1149867, 1149868, 1149869, 1149871, 1149877, 1149878, 1149879, 1149880, 1149881, 1149882, 1149883, 1217194, 1217195, 1217196, 1217197, 1217199, 1217201, 1217202, 1217204, 1217205, 1217206, 1217207, 1217208, 1217209, 1217210, 1217211, 1217212, 1217215, 1217216, 1217217, 1217218, 1217219, 1217220, 1217221, 1217223, 1217226, 1217227, 1217228, 1217231, 1217232, 1217234, 1217235, 1217236, 1217237, 1217238, 1217239, 1217241, 1217242, 1217244, 1217245, 1217246, 1217248, 1217249, 1217250, 1217251, 1217252, 1217255, 1276571, 1276572, 1276573, 1276574, 1276575, 1276576, 1276577, 1276578, 1276579, 1276580, 1276581, 1276582, 1276583, 1276584, 1376074, 1376075, 1376077, 1376078, 1376080, 1376083, 1376086, 1376087, 1376088, 1395870, 1395871, 1395872, 1395873, 1395874, 1395875, 1395877, 1395878, 1395879, 1395880, 1395882, 1395885, 1395886, 1462604, 1462605, 1462607, 1462608, 1476789, 1476790, 1476792, 1476793, 1476794, 1476795, 1476796, 1476798, 1476799, 1476800, 1500489, 1500490, 1500492, 1500495, 1500496, 1500497, 1500498, 1500499, 1500500, 1500501, 1500502, 1500503, 1500504, 1500505, 1500506, 1500507, 1500510, 1500511, 1500512, 1500513, 1562956, 1562957, 1562958, 1562959, 1562960, 1562961, 1562

UPC codes

10885862022066, 10885862022165

Source

Official record: FDA (Device enforcement) ↗

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