—#138328

Product

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.

FDA product code: JEY — Plate, Bone
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K083388
Affected lot / code info: Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260

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.

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. Customers were asked to check their inventory and return affected devices with the completed response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

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

Timeline

Recall initiated: 2015-06-24
Posted by FDA: 2015-07-28
Terminated: 2016-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.