Class II — Potential Health Hazard

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

Drill Template and the Saw Guide for the Ulna Osteotomy Recalled by Synthes, Inc. Due to The Drill Template and the Saw Guide for...

Date: January 7, 2014
Company: Synthes, 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 Synthes, Inc. directly.

Affected Products

Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

Quantity: 343

Why Was This Recalled?

The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Synthes, Inc.

Synthes, Inc. has 43 total recalls tracked by RecallDetector.

Related Recalls

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