Exactech Connexion GXL acetabular polyethylene liners used in the… — Class II medical device recall Z-2131-2021
Ongoing recall by Exactech, Inc., reported 2021-07-28, distributed nationwide. Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain i
| Recall number | Z-2131-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2021-06-29 |
| Classified | 2021-07-22 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 89,050 total |
| UPC / GTIN / UDI-DI | 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671 |
| Serial numbers | 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671 |
| Model numbers | 138-28-XX |
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Reason for recall
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
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-2131-2021. 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.