FDA Device recall Z-1725-2022
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-1725-2022 |
| 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. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
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 144-28-05, GUIDID 10885862027405, Serial Numbers: 646995, 646996, 646997, 646998, 667989, 667990, 667992, 66799…a. REF 144-28-05, GUIDID 10885862027405, Serial Numbers: 646995, 646996, 646997, 646998, 667989, 667990, 667992, 667995, 667996, 668002, 668003, 668004, 770434, 770436, 770440, 770442, 770443, 770444, 863939, 863940, 863943, 863944, 863946, 863948, 1242282, 1242283, 1242284, 1242286, 1242287, 1242288, 1242290, 1242291, 1242292, 1617713, 1617715, 1617717, 1617718, 1617719, 1617720, 1617721, 1869774, 1869775, 1869776, 1869777, 1907611, 1907612, 1907613, 1907614, 1961038, 1961039, 1961040, 1961041, 1961042, 2019292, 2019293, 2019294, 2019295, 2174511, 2174512, 2175232, 2314993, 2314995, 2681417, 2681418, 2681428,; b. REF 144-28-06, GUIDID 10885862027412, Serial Numbers: 647081, 647082, 647083, 647084, 647085, 656277, 656278, 656279, 656281, 667456, 667459, 667466, 667467, 667468, 667470, 667471, 667472, 667474, 667475, 667476, 667477, 736674, 736675, 736677, 736678, 736684, 736685, 736687, 736688, 736689, 736691, 736692, 736695, 736697, 736698, 736704, 736705, 736706, 736707, 736710, 7 |
|---|
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-1725-2022%22
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