Data Foundry

Medical device recalls 2022

GXL acetabular liners — Class II medical device recall Z-1732-2022

Ongoing recall by Exactech, Inc., reported 2022-09-21, distributed nationwide. Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device

Recall numberZ-1732-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmExactech, Inc., Gainesville, FL, United States
Recall initiated2022-08-11
Classified2022-09-09
Reported by FDA2022-09-21
DistributedNationwide (US)
Countries outside the USAR, BR, CL, CN, CO, EC, ES, GR, GT, IN, LB, PT
Quantity17,929 units
UPC / GTIN / UDI-DI10885862207029, 10885862207036, 10885862207043, 10885862207050, 10885862207067, 10885862207074, 10885862207081, 10885862207098, 10885862207104, 10885862207111, 10885862208804, 10885862208811, 10885862208828, 10885862220301, 10885862220318, 10885862220325
Serial numbers2406944, 2406954, 2406960, 2408204, 2408207, 2408211, 2408213, 2408215, 2408217, 2408218, 2408226, 2408228, 2408232, 2408233, 2408234, 2408235, 2408236, 2408237, 2408238, 2408240, 2408243, 2408244, 2408245, 2408246, 2408247 and 475 more
Model numbers130-32-51, 130-36-52, 130-40-53, 130-40-54, 130-40-55, 132-32-51, 132-36-52, 132-40-53, 132-40-54, 132-40-55, 136-40-53, 136-40-54, 136-40-55, 138-40-53, 138-40-54, 138-40-55

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 for recall

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1732-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.