Synthes (USA) Products LLC recalls Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2m…

Recall date

June 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2272-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.