Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion p...

FDA Device Recall #Z-2120-2012 — Class II — June 15, 2012

Recall Summary

Recall Number Z-2120-2012
Classification Class II — Moderate risk
Date Initiated June 15, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Exactech, Inc.
Location Gainesville, FL
Product Type Devices
Quantity 54,877 units for all products in Recall Event

Product Description

Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).

Reason for Recall

Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

Distribution Pattern

Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.

Lot / Code Information

Sizes: 5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers

Other Recalls from Exactech, Inc.

Recall # Classification Product Date
Z-1510-2026 Class II Brand Name: Equinoxe Product Name: Equinoxe C... Feb 3, 2026
Z-1509-2026 Class II Brand Name: Equinoxe Ergo Product Name: Ergo M... 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.