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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer ITST

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  Class 2 Device Recall Zimmer ITST see related information
Date Initiated by Firm June 05, 2009
Date Posted August 04, 2009
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-1701-2009
Recall Event ID 52226
510(K)Number K032367  
Product Classification orthopedic surgical instrument - Product Code HSB
Product Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
Code Information Lots 60633223 and 60740476.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
FDA Determined
Cause 2
Process control
Action Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products.
Quantity in Commerce 120 of both products
Distribution Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
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 = HSB and Original Applicant = ZIMMER, INC.