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 130 Degree Aiming Arm and 125 Degree Aiming Arm Recalled by Synthes, Inc. Due to The guide sleeve has the potential to jam...

Date: February 24, 2015
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 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Quantity: 131

Why Was This Recalled?

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

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