Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-2272-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

Product Classification:

Class II

Date Initiated: June 24, 2015

Date Posted: August 5, 2015

Recall Number: Z-2272-2015

Event ID: 71595

Reason for Recall:

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

Status: Terminated

Product Quantity: 31

Code Information:

Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260

Distribution Pattern:

Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.

Voluntary or Mandated:

Voluntary: Firm initiated