Class 2 Device Recall Foundation Hip System Bipolar Modular

• Date Initiated by Firm: August 02, 2007
• Date Posted: November 07, 2007
• Recall Status: Terminated on January 09, 2008
• Recall Number: Z-0097-2008
• Recall Event ID: 44788
• 510(K)Number: K953510
• Product Classification: hip prosthesis - Product Code KWY
• Product: Foundation¿ Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
• Code Information: Lot #: 627751, 629111, 678981, 678991, 679001, 690231, 210192, 695841, 855041, 875561, 882671, 894381, 905671, 9072291, 939741, 949611 and 964521.
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• For Additional Information Contact: 512-834-6235
• Manufacturer Reason for Recall: Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
• FDA Determined Cause: Packaging change control
• Action: Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
• Quantity in Commerce: 86 units.
• Distribution: Worldwide, including USA, Greece, Japan, and Saudi Arabia.
• 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 = KWY and Original Applicant = ENCORE ORTHOPEDICS, INC.