FDA Device recall Z-1734-2022
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-1734-2022 |
| 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. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665
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 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982…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 |
|---|
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-1734-2022%22
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