Z-2272-2015Class II

Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary...

Name: Z-2272-2015 Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary...
Creator: Synthes (USA) Products LLC
Published: 2015-06-24
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-06-24 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2015-06-24. FDA classified it as Class II and gives the reason as "The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2272-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-07-28
Terminated: 2016-08-18
Recalling firm: Synthes (USA) Products LLC
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.
Product code: JEY Plate, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 31
Distribution: Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.
Product codes and lots: Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2272-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2272-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-28

Product code JEY

K083388Class IISynthes Matrixorthognathis Fixation SystemSynthes (Usa) / cleared 2009-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)