Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.

FDA device recall Z-1833-2014 · posted 2014-06-19 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

Action taken

Synthes sent an Urgent Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: All Synthes External Fixation devices should be treated as MR Conditional. " Synthes asks that you review the information contained in this Labeling Notification and complete the Verification Section located on Page 3. " Discard outdated revisions of the Technique Guides noted in the table below. " Update your records with updated Labeling Infonnation. " Forward this Medical Device Labeling Update to anyone in your facility that needs to be infonned, especially those personnel that conduct MR testing. " If the Verification Fonn is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in pg. 3. " Updated product literature can be located on the Synthes website at http://www.syntheskyo.com/trauma kyo/home/home.htm. " Please see the attached inseii for current conditions for use in the MR environment. " Maintain a copy of this notice. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Root cause

Labeling Change Control

Status

Terminated

Product code

KTT

Quantity affected

5,114,052

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2014-04-10

Date posted

2014-06-19

Date terminated

2016-08-26

Location

West Chester, PA

Related 510(k) clearances