Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Octane-C Cervical Recalled by Exactech, Inc. Due to Exactech, Inc. initiated a recall of Equinoxe Replicator...

Date: June 15, 2012
Company: Exactech, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.

Affected Products

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

Quantity: 54,877 units for all products in Recall Event

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 27 states: AL, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA

Affected (27 states)Not affected

About Exactech, Inc.

Exactech, Inc. has 211 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report