GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM

Summary

The FDA issued a Class II for GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: by Exactech, Inc.. Reason: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear..

Details

Product Description

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 ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

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, 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5210695, 5210696, 5210697, 5211374, 5305194, 5305195, 5305196, 5305197, 5305198, 5305199, 5305201, 5305202, 5305203, 5305206, 5305207, 5305208, 5305211, 5305212, 5305213, 5305214, 5305216, 5305218, 5305219, 5305223, 5545307, 5545309, 5545310, 5545313, 5545314, 5545316, 5545321, 5545324, 5545327, 5836331; b. REF 130-32-52, GUDID 10885862022165, Serial Numbers: 1024814, 1024815, 1024816, 1024817, 1024818, 1024820, 1024821, 1024822, 1024823, 1024824, 1024825, 1024826, 1024827, 1024828, 1024829, 1024830, 1024831, 1024832, 1024833, 1024834, 1024835, 1024836, 1024837, 1024838, 1024839, 1024840, 1024841, 1024842, 1024844, 1024845, 1024846, 1024847, 1024848, 1024850, 1024851, 1024852, 1024853, 1024854, 1024855, 1024856, 1024857, 1024858, 1024859, 1024860, 1024861, 1024862, 1024863, 1024864, 1024865, 1024866, 1024867, 1024868, 1024869, 1024870, 1024871, 1024872, 1024873, 1024874, 1024875, 1024876, 1024877, 1024879, 1024880, 1024881, 1024882, 1104230, 1104231, 1104232, 1104233, 1104235, 1104236, 1104237, 1104238, 1104240, 1104241, 1104242, 1104243, 1104244, 1104245, 1104247, 1104248, 1104249, 1104250, 1104253, 1104256, 1104257, 1104258, 1104260, 1104261, 1104262, 1144217, 1144218, 1144221, 1144222, 1144223, 1144224, 1144225, 1144226, 1144227, 1144228, 1144229, 1144230, 1144231, 1144232, 1144233, 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3644688, 3644689, 3644690, 3644691, 3644692, 3644693, 3644694, 3644695, 3644696, 3644697, 3644698, 3644699, 3644700, 3644701, 3644702, 3644703, 3644704, 3644705, 3644706, 3644707, 3644708, 3644709, 3665240, 3665241, 3665242, 3665243, 3665244, 3665245, 3665246, 3665247, 3665248, 3665249, 3665250, 3665251, 3665252, 3665253, 3665254, 3665255, 3665256, 3665257, 3665258, 3665259, 3665260, 3665261, 3665262, 3665263, 3665264, 3665265, 3665266, 3702615, 3702616, 3702617, 3702618, 3702619, 3702620, 3702621, 3702622, 3702623, 3702624, 3702625, 3702626, 3702627, 3702628, 3702757, 3702758, 3702759, 3702760, 3702761, 3702762, 3702763, 3702764, 3702765, 3702766, 3707228, 3707229, 3707230, 3707231, 3707232, 3707233, 3707234, 3707235, 3707236, 3707237, 3707238, 3707239, 3707240, 3707241, 3707242, 3707243, 3707244, 3707245, 3707246, 3707247, 3707248, 3707249, 3707250, 3707251, 3707252, 3707253, 3712186, 3712187, 3712188, 3712189, 3712190, 3712191, 3712192, 3712193, 3712194, 3712195, 3712196, 3712197, 3712198, 3712199, 3712200, 3712201, 3712202, 3712203, 3712204, 3712205, 3712206, 3712207, 3712208, 3712209, 3712210, 3712211, 3712212, 3712213, 3712214, 3712215, 3712216, 3712217, 3712218, 3712219, 3712220, 3712221, 3712222, 3712223, 3712224, 3712225, 3712226, 3712227, 3747040, 3747041, 3747042, 3747043, 3747044, 3747

Quantity Affected: 58158 devices

Reason for Recall

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

Type: Voluntary: Firm initiated

Recall Initiated: 2022-08-11

Company