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 Flexible Medullary Reamer. Intended to be used to facilitate Recalled by Synthes USA HQ, Inc. Due to Foreign Object Contamination

Date: June 11, 2013
Company: Synthes USA HQ, 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 USA HQ, Inc. directly.

Affected Products

Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

Quantity: 13,050

Why Was This Recalled?

Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Synthes USA HQ, Inc.

Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.

Related Recalls

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