Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

FDA Device Recall #Z-0459-2021 — Class II — October 6, 2020

Recall Summary

Recall Number Z-0459-2021
Classification Class II — Moderate risk
Date Initiated October 6, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Exactech, Inc.
Location Gainesville, FL
Product Type Devices
Quantity 69 devices

Product Description

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

Reason for Recall

The product may be mislabeled.

Distribution Pattern

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

Lot / Code Information

Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318

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.