Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06;

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: 7946 devices Lot/code info: a. REF 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982; b. REF 130-28-06, GUDID 10885862021922, Serial Numbers: 618681, 618682, 618683, 618686, 618688, 618691, 618693, 618696, 618697, 618698, 618699, 618701, 691919, 691920, 691924, 708701, 708703, 708705, 708706, 708707, 708708, 708709, 786731, 786732, 786733, 786740, 786741, 786742, 786743, 786745, 786746, 786747, 786748, 786751, 786752, 786755, 786756, 786758, 786760, 786761, 786762, 1369855, 1369856, 1369857, 1369858, 1369861; c. REF 130-28-07, GUDID 10885862021939, Serial Numbers: 569785, 569786, 569787, 570965, 570966, 570968, 570970, 570971, 570972, 570973, 570974, 570975, 570976, 570977, 570979, 570980, 570981, 570982, 583427, 583428, 583429, 583430, 583431, 583432, 583434, 583435, 583436, 583437, 583438, 583439, 583441, 583443, 583444, 583445, 583446, 583447, 583448, 583451, 583452, 656293, 656298, 656299, 656302, 656303, 656306, 656307, 656309, 656312, 656314, 712635, 712636, 712637, 712638, 712643, 712644, 712646, 712647, 712650, 712651, 712652, 712657, 712659, 712660, 810722, 810723, 810726, 810727, 810729, 810730, 810731, 810737, 810738, 810739, 810741, 810742, 810743, 810745, 810747, 810748; d. REF 130-28-08, GUDID 10885862021946, Serial Numbers: 625182, 625185, 625186, 625187, 625192, 625193, 625194, 625195, 625196, 625197, 625206, 625207, 690375, 690376, 690378, 690379, 690380, 765865, 765867, 765868, 765877; e. REF 130-28-09, GUDID 10885862021953,

UPC codes

10885862021915, 10885862021922, 10885862021939, 10885862021946, 10885862021953, 10885862022899, 10885862022905, 10885862022912, 10885862022929, 10885862022936, 10885862023001, 10885862023018, 10885862023025

Source

Official record: FDA (Device enforcement) ↗

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