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Synthes TomoFix Plates recallZ-0473-2014 · Synthes USA HQ, Inc. · initiated Oct 9, 2013

Class II Terminated All recalls posted in December 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-0473-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 9, 2013
Posted by the FDA
Dec 10, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
2912
Product code
KTT
FDA submissions
K023941
Distribution
Worldwide Distribution - USA (nationwide) Canada and Mexico

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.

Code information (models, lots, serial numbers)

J5606-C

Other devices under the same FDA submission

7 devices cleared under K023941 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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