Date Initiated by Firm |
August 04, 2008 |
Date Posted |
September 29, 2008 |
Recall Status1 |
Terminated 3 on August 03, 2009 |
Recall Number |
Z-2466-2008 |
Recall Event ID |
49116 |
510(K)Number |
k923277 k941306 k960008 k970031
|
Product Classification |
Prosthesis, knee - Product Code JWH
|
Product |
FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant. |
Code Information |
All Revision A and Revision B Impactors. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact |
512-832-9500
|
Manufacturer Reason for Recall |
Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
|
FDA Determined Cause 2 |
Device Design |
Action |
Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance. |
Quantity in Commerce |
68 units. |
Distribution |
FL and TX and OUS: Japan. |
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 = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
|