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

FDA device recall Z-0473-2014 · posted 2013-12-10 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KTT

Quantity affected

2912

Distribution

Worldwide Distribution - USA (nationwide) Canada and Mexico

Date initiated

2013-10-09

Date posted

2013-12-10

Date terminated

2015-12-18

Location

West Chester, PA

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