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U.S. Department of Health and Human Services

Class 2 Device Recall EPIK KNEE SYSTEM Angled Insert Impactor

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  Class 2 Device Recall EPIK KNEE SYSTEM Angled Insert Impactor see related information
Date Initiated by Firm August 09, 2007
Date Posted October 10, 2007
Recall Status1 Terminated 3 on March 10, 2008
Recall Number Z-0009-2008
Recall Event ID 38951
510(K)Number K020741  K022437  
Product Classification knee prosthesis instrument - Product Code HRY
Product EPIK¿ KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Code Information All lots.
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
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 = HRY and Original Applicant = ENCORE MEDICAL, L.P.
510(K)s with Product Code = HRY and Original Applicant = ENCORE ORTHOPEDICS, INC.