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/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Ms. Christie Samsa 201-831-5970
|
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
|