Z-0473-2014Class II

Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge...

Name: Z-0473-2014 Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge...
Creator: Synthes USA HQ, Inc.
Published: 2013-10-09
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-10-09 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral... on 2013-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0473-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Posted: 2013-12-10
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: 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 code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: labeling and UDI
FDA 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 another facility, contact that facility. Maintain awareness of this notice until all surgical technique guides have been exchanged. Maintain a copy of this notice. Customers with questions were instructed to contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 2912
Distribution: Worldwide Distribution - USA (nationwide) Canada and Mexico
Product codes and lots: J5606-C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0473-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-10

Product code KTT

K023941Class IISynthes Tomofix Osteotomy SystemSynthes (Usa) / cleared 2003-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)