Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer ITST

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-1702-2009
Recall Event ID 52226
510(K)Number K032367  
Product Classification orthopedic surgical instrument - Product Code HSB
Product Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
Code Information Lots 60639048 and 60657449.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-371-8603
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.
-
-