Class 2 Device Recall Ascent

• Date Initiated by Firm: May 16, 2005
• Date Posted: August 31, 2005
• Recall Status: Terminated on September 08, 2005
• Recall Number: Z-1453-05
• Recall Event ID: 32124
• Product Classification: Instrument, Cutting, Orthopedic - Product Code HTZ
• Product: Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-large, stainless steel; Ref. RD140633.
• Code Information: Lots 117650, 170870, 229660, 238680, 467310, 491720, 608420, 542570, 491721, 024600, 351170 and 561190.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 800-348-9500
• Manufacturer Reason for Recall: The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
• FDA Determined Cause: Other
• Action: Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.
• Quantity in Commerce: 155
• Distribution: Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
• 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.