Recall Z-1009-2015— Synthes, Inc.

Name: FDA recall Z-1009-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-17

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2014-10-17, terminated 2016-08-18. It names 2 FDA 510(k) clearances: K050378, K040169. Product: The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.. Reason: Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Terminated: 2016-08-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K050378 — SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)·cleared 2005-03-15
K040169 — SYNTHES MANDIBLE EXTERNAL FIXATORSynthes (Usa)·cleared 2004-04-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Reason for recall

Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.

Data sourced from openFDA. This site is unofficial and independent of the FDA.