Date Initiated by Firm |
October 24, 2008 |
Date Posted |
December 18, 2008 |
Recall Status1 |
Terminated 3 on December 31, 2009 |
Recall Number |
Z-0510-2009 |
Recall Event ID |
50172 |
510(K)Number |
K043250
|
Product Classification |
Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
|
Product |
Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102.
Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Stryker Craniomaxillofacial Division 750 Trade Centre Way Ste 200 Portage
|
For Additional Information Contact |
269-324-5346 Ext. 4258
|
Manufacturer Reason for Recall |
Lack of assurance of sterility.
|
FDA Determined Cause 2 |
Process control |
Action |
The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08. |
Quantity in Commerce |
322 of all products. |
Distribution |
Nationwide Distribution. |
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 = STRYKER LEIBINGER
|