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Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm… recallZ-2272-2015 · Synthes (USA) Products LLC · initiated Jun 24, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2272-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 24, 2015
Posted by the FDA
Jul 28, 2015
Recalling firm
Synthes (USA) Products LLC
Quantity
31
Product code
JEY
FDA submissions
K083388
Distribution
Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

38 devices cleared under K083388 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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