Recall Z-0473-2014 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
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.
| Date | Dec 10, 2013 (initiated Oct 9, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| Action | Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter dated October 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exchange the old surgical technique guide version J5606-C with the new version J5606-D provided with this notification. Review the revised surgical technique guide (Pages 25 & 26). Forward this Field Safety Notification to anyone in their facility that need to be informed. If the surgical technique guide has been forwarded to an |
| Quantity | 2912 |
| Distribution | Worldwide Distribution - USA (nationwide) Canada and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023941 | SYNTHES TOMOFIX OSTEOTOMY SYSTEM Synthes (Usa), Jan 23, 2003 |