Z-0473-2014 Class II Terminated
FDA device recall Z-0473-2014 was initiated by Synthes USA HQ, Inc. on Oct 9, 2013 and is designated Class II. 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… The recall status is terminated (terminated Dec 18, 2015). Affected quantity: 2912.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Oct 9, 2013
- Termination Date
- Dec 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2912
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Canada and Mexico
Code Information
J5606-C