FDA Device recall Z-1733-2022
GXL acetabular liners, orthopedic hip implant component
- FDA Device
- Class II
- ongoing
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class II recall of GXL acetabular liners, orthopedic hip implant component by Exactech, citing specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1733-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-11 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | US |
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
Reason
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Identifiers
| code_info | a. REF 106-22-42, GUDID 10885862014337, Serial Numbers: 609855, 609856, 609857, 609858, 609859, 609860, 609862, 609863…a. REF 106-22-42, GUDID 10885862014337, Serial Numbers: 609855, 609856, 609857, 609858, 609859, 609860, 609862, 609863, 609864, 609865, 609867, 609868, 609869, 609870, 609871, 609873, 609874, 609878, 609879, 609880, 914353, 914354, 914355, 914356, 914357, 914358, 914359, 914360, 914361, 914362, 914363, 914364, 996721, 996722, 996723, 996724, 996725, 996726, 996727, 996728, 996730, 996731, 996732, 996733, 996734, 996735, 996736, 996737, 996738, 996739, 1049244, 1049245, 1049246, 1049247, 1068758, 1068759, 1068760, 1068761, 1068762, 1068763, 1068765, 1068766, 1068767, 1068768, 1068769, 1068770, 1068771, 1068772, 1068773, 1068774, 1068775, 1068776, 1068777, 1068778, 1229946, 1229947, 1229948, 1229949, 1229950, 1229951, 1229952, 1229953, 1229954, 1229955, 1229956, 1332136, 1332137, 1332138, 1332139, 1332140, 1358473, 1358475, 1358476, 1358477, 1358478, 1514277, 1514278, 1514279, 1514280, 1514281, 1514282, 1514283, 1514284, 1514285, 1514286, 1514287, 1514288, 1514289, 1514290, 1514291, 151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1733-2022%22
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