External Mandibular Fixator And/or Distractor

The Synthes Mandible External Fixator; all lots of part nos.:

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.

DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

Synthes CMF Distraction System

The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.

TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.

TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975

DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.