FDAFDA · Food and drugs·Recall number Z-0473-2014
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.
Published December 18, 2013 · Recall initiated: October 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) Canada and Mexico
- Lot
- J5606-C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.