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 Trauma Nail System. The devices are indication for bone fixation. Recalled by Synthes USA HQ, Inc. Due to Recall was initiated due to the possibility that...

Date: November 2, 2012
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 Trauma Nail System. The devices are indication for bone fixation.

Quantity: 1,011,783

Why Was This Recalled?

Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

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