Class 2 Device Recall ALFA II Modular Femoral Revision Stem

• Date Initiated by Firm: April 12, 2007
• Date Posted: July 23, 2007
• Recall Status: Terminated on July 25, 2007
• Recall Number: Z-1063-2007
• Recall Event ID: 37881
• 510(K)Number: K000817
• Product Classification: Hip replacement prosthesis component - Product Code JDI
• Product: ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758.
• Code Information: Lot # Y031E.
• FEI Number: 1000116912
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• Manufacturer Reason for Recall: Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
• FDA Determined Cause: Other
• Action: Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
• Quantity in Commerce: 3 units.
• Distribution: Product distributed to surgical centers in CT, KS and MO.
• 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 = JDI