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U.S. Department of Health and Human Services

Class 2 Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlay

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 Class 2 Device Recall OMNIPORE Surgical Implant Design Y Mandible Onlaysee related information
Date Initiated by FirmJanuary 25, 2017
Date PostedFebruary 28, 2017
Recall Status1 Terminated 3 on May 24, 2017
Recall NumberZ-1382-2017
Recall Event ID 76356
510(K)NumberK123908 K133046 
Product Classification Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
ProductOP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Code Information OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
FEI Number 3009383407
Recalling Firm/
Manufacturer		 Matrix Surgical Holdings, LLC
4025 Welcome All Rd Sw Ste 120
Atlanta GA 30349-1876
For Additional Information ContactJohn T. O'Shaughnessy
404-862-3794
Manufacturer Reason
for Recall		Mislabeling. The packaging labeled as left mandible contained a right mandible.
FDA Determined
Cause 2		Other
ActionMatrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.
Quantity in Commerce28
DistributionWorldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KKY
510(K)s with Product Code = KKY
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