Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and pr

FDA device recall Z-2451-2015 · posted 2015-08-24 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported.

Action taken

Urgent recall letters, dated July 31, 2015, were sent to end users and sales consultants to notifiy them about the issue, the associated risks, and to provide instructions for returning the affected devices and response form.

Root cause

Labeling design

Status

Terminated

Product code

KTT

Quantity affected

5306080

Distribution

Worldwide Distribution-including US (nationwide) and Canada.

Date initiated

2015-07-29

Date posted

2015-08-24

Date terminated

2016-09-27

Location

West Chester, PA

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