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 Driving Cap/Threaded Both parts are intended for use in Recalled by Synthes, Inc. Due to The Synthes Driving Cap/Threaded can bind in the...

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

Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.

Quantity: 143

Why Was This Recalled?

The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.

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