Class II — Potential Health Hazard

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

Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set Recalled by Synthes, Inc. Due to A screw set was returned from the field...

Date: June 30, 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

Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

Quantity: 4

Why Was This Recalled?

A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

Where Was This Sold?

This product was distributed to 2 states: MI, WI

Affected (2 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