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.
This recall has been terminated (originally issued January 23, 2015).
- Company
- Synthes, Inc.
- Recall Initiated
- October 17, 2014
- Posted
- January 23, 2015
- Terminated
- August 18, 2016
- Recall Number
- Z-1009-2015
- Quantity
- 43159
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution.
Lot / Code Info
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
Root Cause
Labeling design
Action Taken
Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.