GXL acetabular liners — Class II medical device recall Z-1733-2022
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 number | Z-1733-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2022-08-11 |
| Classified | 2022-09-09 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CL, CN, CO, EC, ES, GR, GT, IN, LB, PT |
| Quantity | 4,956 devices |
| UPC / GTIN / UDI-DI | 10885862014337, 10885862014344, 10885862014351, 10885862014368, 10885862014375, 10885862014382, 10885862014603, 10885862014610, 10885862014627, 10885862014634, 10885862014641, 10885862014658, 10885862014665, 10885862014726, 10885862014733, 10885862014740, 10885862014757, 10885862014764 |
| Serial numbers | 1003409, 1003412, 1003415, 1003416, 1003418, 1003425, 1003426, 1003427, 1003428, 1003429, 1003430, 1003431, 1003432, 1003433, 1003434, 1003435, 1003436, 1003437, 1003438, 1003439, 1003440, 1003441, 1003442, 1003443, 1003444 and 475 more |
| Model numbers | 106-22-42, 106-22-44, 106-22-46, 106-22-48, 106-22-50, 106-22-52, 106-22-54, 106-28-48, 106-28-50, 106-28-52, 106-28-54, 106-28-56, 106-28-58, 106-28-60, 106-32-52, 106-32-54, 106-32-56, 106-32-58, 106-32-60 |
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
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-1733-2022. 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.