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U.S. Department of Health and Human Services

Class 2 Device Recall TI Matrix PreBent Maxillary Plates

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  Class 2 Device Recall TI Matrix PreBent Maxillary Plates see related information
Date Initiated by Firm June 24, 2015
Date Posted July 28, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-2272-2015
Recall Event ID 71595
510(K)Number K083388  
Product Classification Plate, bone - Product Code JEY
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.
Code Information Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260  
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JEY and Original Applicant = SYNTHES (USA)
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