Class II — Potential Health Hazard

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

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). Recalled by Biomet, Inc. Due to It was reported that the number scale/graduation markings...

Date: November 9, 2012
Company: Biomet, 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 Biomet, Inc. directly.

Affected Products

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

Quantity: 49

Why Was This Recalled?

It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

Where Was This Sold?

This product was distributed to 7 states: CA, FL, MI, NY, PA, TN, TX

Affected (7 states)Not affected

About Biomet, Inc.

Biomet, Inc. has 250 total recalls tracked by RecallDetector.

Related Recalls

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