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-0094-2008
• Recall Event ID: 44788
• 510(K)Number: K953510
• Product Classification: hip prosthesis - Product Code KWY
• Product: Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
• Code Information: Lot #: 624421, 676851, 676861, 677151, 678901, 678911, 678921, 693271, 695151, 738501, 739461, 770171, 777501, 777511, 781071, 788561, 794451, 814351, 830981, 830991, 855011, 875541, 878451, 894301, 894311, 894321, 907261, 933911, 949561 and 949571.
• 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: 171 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