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U.S. Department of Health and Human Services

Class 2 Device Recall MEDPORE Craniofacial Implants with Embedded Titanium Mesh

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  Class 2 Device Recall MEDPORE Craniofacial Implants with Embedded Titanium Mesh see related information
Date Initiated by Firm December 29, 2021
Create Date March 03, 2022
Recall Status1 Terminated 3 on December 21, 2023
Recall Number Z-0715-2022
Recall Event ID 89458
510(K)Number K040364  
Product Classification Mesh, surgical - Product Code FTM
Product MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Code Information UDI: 07613252084334; Lot Number: 3R7YHD
Recalling Firm/
Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
Manufacturer Reason
for Recall
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
FDA Determined
Cause 2
Process control
Action An URGENT MEDICAL DEVICE Recall notification letter dated 12/29/21 was sent to customers. Actions needed 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Return the enclosed business reply form by email to CMF-custserv@stryker.com to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, we will contact you to arrange for the return and replacement of your affected product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform a Stryker representative if any of the subject devices have been distributed to other organizations. If so, provide contact details so that we may inform the recipients appropriately. If you have any questions or concerns, please contact Customer Service +1 800 962-6558.
Quantity in Commerce 74
Distribution Worldwide distribution - US Nationwide.
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 = FTM and Original Applicant = POREX SURGICAL, INC.