FDA Device recall Z-1732-2022
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-1732-2022 |
| 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. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
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 130-32-51, GUDID 10885862207074, Serial Numbers: 2409984, 2409985, 2409986, 2409987, 2409988, 2409989, 2409990,…a. REF 130-32-51, GUDID 10885862207074, Serial Numbers: 2409984, 2409985, 2409986, 2409987, 2409988, 2409989, 2409990, 2409991, 2409993, 2409994, 2409995, 2409996, 2409997, 2409998, 2409999, 2410000, 2410001, 2410002, 2410003, 2410004, 2410005, 2410006, 2410007, 2410008, 2410009, 2410010, 2410011, 2410012, 2410013, 2410014, 2424081, 2424082, 2424083, 2424084, 2424085, 2424086, 2424087, 2424088, 2424089, 2424090, 2424091, 2424092, 2424093, 2424094, 2424096, 2424097, 2424098, 2424099, 2424100, 2433191, 2433192, 2433193, 2433194, 2433195, 2433196, 2433197, 2433198, 2433199, 2433200, 2433201, 2433202, 2433203, 2433204, 2433205, 2433206, 2433207, 2433208, 2433209, 2433210, 2433211, 2581934, 2581935, 2581936, 2581937, 2581938, 2581939, 2581940, 2581941, 2581942, 2581943, 2581944, 2581945, 2581946, 2581947, 2581948, 2581950, 2581951, 2581952, 2581953, 2581954, 2581955, 2581956, 2581957, 2581958, 2581959, 2581960, 2581961, 2581962, 2581963, 2581964, 2581965, 2581966, 2581967, 2581968, 2581969 |
|---|
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-1732-2022%22
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