Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numb...

FDA Device Recall #Z-2130-2021 — Class II — June 29, 2021

Recall Summary

Recall Number Z-2130-2021
Classification Class II — Moderate risk
Date Initiated June 29, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Exactech, Inc.
Location Gainesville, FL
Product Type Devices
Quantity 89,050 total

Product Description

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. 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.

Distribution Pattern

Distribution US nationwide.

Lot / Code Information

All serial numbers. UDI-DI number: 10885862024503

Other Recalls from Exactech, Inc.

Recall # Classification Product Date
Z-1509-2026 Class II Brand Name: Equinoxe Ergo Product Name: Ergo M... Feb 3, 2026
Z-1510-2026 Class II Brand Name: Equinoxe Product Name: Equinoxe C... Feb 3, 2026
Z-0536-2026 Class II Brand Name: Equinoxe Ergo Product Name: Adjust... Sep 5, 2025
Z-0537-2026 Class II Brand Name: Equinoxe Ergo Product Name: Ergo A... Sep 5, 2025
Z-0535-2026 Class II Brand Name: Equinoxe Ergo Product Name: Adjust... Sep 5, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.