Class 2 Device Recall Insall/Burstein II Modular Knee System, Tibial Wedge

• Date Initiated by Firm: February 26, 2009
• Date Posted: December 22, 2009
• Recall Status: Terminated on February 28, 2011
• Recall Number: Z-0555-2010
• Recall Event ID: 51219
• 510(K)Number: K862632
• Product Classification: knee prosthesis component - Product Code HSX
• Product: Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
• Code Information: Lot 07878240.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: Smaller diameter screws than required were included in the package.
• FDA Determined Cause: Process control
• Action: Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
• Quantity in Commerce: 13
• Distribution: USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland 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.

• 510(K) Database: 510(K)s with Product Code = HSX and Original Applicant = ZIMMER, INC.