FDA Device recall Z-1727-2022
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-1727-2022 |
| 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 +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09 e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10
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 138-36-08, GUDID 10885862024787, Serial Numbers: 638430, 638433, 638451, 638462, 638467; b. REF 138-36-09,…a. REF 138-36-08, GUDID 10885862024787, Serial Numbers: 638430, 638433, 638451, 638462, 638467; b. REF 138-36-09, GUDID 10885862024794, Serial Numbers: 635279, 635281; c. REF 132-36-08, GUDID 10885862023353, Serial Numbers: 630606, 630607, 630609, 630610, 630611, 630612, 630613, 632796, 632797, 632799, 632800, 632801, 632802, 632803, 632805, 632806, 632807, 632808, 632809, 632810, 632812, 632813, 632814, 632815, 632817, 632818, 632819, 632822, 632823, 632824, 632826, 632829, 632830, 632832, 632834, 657859, 657861, 657862, 657863, 657865, 657866, 657867, 657868, 657869, 657870, 657871, 657873, 657875, 657876, 657877, 657878, 657880, 657882, 657883, 657885, 657886, 657887, 657888, 657890, 657891, 657892, 1116881, 1116882, 1116883, 1116886, 1116887, 1116888, 1116889, 1116890, 1116892, 1116896, 1116897, 1116899, 1116903, 1116904, 1116905; d. REF 132-36-09, GUDID 10885862023360, Serial Numbers: 638946, 638947, 638950, 643861, 643862, 643863, 643864, 643865, 643866, 643867, 64 |
|---|
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-1727-2022%22
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