GXL acetabular liners — Class II medical device recall Z-1730-2022
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-1730-2022 |
|---|---|
| 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 | 2,319 devices |
| UPC / GTIN / UDI-DI | 10885862023971, 10885862023988, 10885862024022, 10885862024039, 10885862024046 |
| Serial numbers | 1152706, 1152707, 1152709, 1152711, 1152712, 1152713, 1152714, 1152716, 1152717, 1152719, 1152721, 1152722, 1152724, 1152725, 1152727, 1152728, 1152729, 1152730, 1152731, 1152732, 1152735, 1152736, 1152737, 1152739, 1152740 and 475 more |
| Model numbers | 134-28-41, 134-32-42, 134-36-43, 134-36-44, 134-36-45 |
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
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-1730-2022. 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.