Class 2 Device Recall EPIK KNEE SYSTEM Angled Insert Impactor

• Date Initiated by Firm: August 09, 2007
• Date Posted: October 10, 2007
• Recall Status: Terminated 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: 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; 510(K)s with Product Code = HWA