Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0473-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Product Classification:

Class II

Date Initiated: October 9, 2013

Date Posted: December 18, 2013

Recall Number: Z-0473-2014

Event ID: 66582

Reason for Recall:

A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.

Status: Terminated

Product Quantity: 2912

Code Information:

J5606-C

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Canada and Mexico

Voluntary or Mandated:

Voluntary: Firm initiated