Class II — Potential Health Hazard

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

2.5 mm Reaming Rod Recalled by Synthes (USA) Products LLC Due to Possible lack of product sterility due to potential...

Date: July 26, 2017
Company: Synthes (USA) Products LLC
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) Products LLC directly.

Affected Products

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Quantity: 6257

Why Was This Recalled?

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Synthes (USA) Products LLC

Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.

Related Recalls

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