Date Initiated by Firm |
August 09, 2007 |
Date Posted |
October 10, 2007 |
Recall Status1 |
Terminated 3 on March 10, 2008 |
Recall Number |
Z-0010-2008 |
Recall Event ID |
38951 |
510(K)Number |
K020741 K022437
|
Product Classification |
knee prosthesis instrument - Product Code HWA
|
Product |
EPIK¿ KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact |
512-834-6235
|
Manufacturer Reason for Recall |
Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
|
FDA Determined Cause 2 |
Device Design |
Action |
Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements. |
Quantity in Commerce |
5 units. |
Distribution |
Products distributed to direct accounts in CA, FL and MD. |
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 = HWA and Original Applicant = ENCORE MEDICAL, L.P. 510(K)s with Product Code = HWA and Original Applicant = ENCORE ORTHOPEDICS, INC.
|