Class II — Potential Health Hazard

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

OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5 Recalled by Exactech, Inc. Due to Exactech, Inc. of Gainesville, FL recalled their Optetrak...

Date: October 17, 2011
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

OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

Quantity: 70

Why Was This Recalled?

Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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