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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Insall/Burstein II Modular Knee System, Tibial Wedge see related information
Date Initiated by Firm February 26, 2009
Date Posted December 22, 2009
Recall Status1 Terminated 3 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
Smaller diameter screws than required were included in the package.
FDA Determined
Cause 2
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.