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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CMF Customized Implant Kit

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  Class 2 Device Recall Stryker CMF Customized Implant Kit see related information
Date Initiated by Firm December 06, 2013
Date Posted February 12, 2014
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-0975-2014
Recall Event ID 67384
510(K)Number K103010  
Product Classification Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
Product Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2)
5444-01-102 Host Bone; Howmedica Osteonics Corp.
325 Corporate Drive, Mahwah, NJ 07430 USA.

Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

Code Information 510 K103010 Catalog # 5444-0-400 Lot Code K08702VR21FEB
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Christie Samsa
Manufacturer Reason
for Recall
Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
FDA Determined
Cause 2
Labeling Change Control
Action Stryker Orthopaedics sent Urgent Medical Device Recall Notification letters/Product Recall Acknowledgement Forms dated 12/6/2013 to US branch/agency. surgeons, hospital risk managers, and sales representatives.
Quantity in Commerce one unit
Distribution Distributed in PA.
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 = KKY and Original Applicant = HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS