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 Trabecular Metal Reverse Shoulder System

  • 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 Trabecular Metal Reverse Shoulder System see related information
Date Initiated by Firm July 20, 2006
Date Posted August 26, 2006
Recall Status1 Terminated 3 on December 19, 2007
Recall Number Z-1416-06
Recall Event ID 35942
510(K)Number K052906  
Product Classification Shoulder System - Product Code KWT
Product Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
Code Information All lots.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 Components may not lock together as intended.
FDA Determined
Cause 2		 Other
Action Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
Quantity in Commerce 197 for all three recalls Z-1416-1418-06
Distribution Worldwide distribution --- USA and countries of Australia and China
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 = KWT and Original Applicant = ZIMMER, INC.
-
-