Plate, Bone（JEY）

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

Custom surgical kits contain a plate different than indicated by the package labeling.

Custom surgical kits contain a plate different than indicated by the package labeling.

The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.

There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.