• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DTO" Implant

  • 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 | Inspections

New Search Back to Search Results
 Class 2 Recall
DTO" Implant
see related information
Date Posted November 06, 2012
Recall Status1 Terminated on April 16, 2014
Recall Number Z-0241-2013
Recall Event ID 63103
Premarket Notification
510(K) Number
Product Classification Posterior Metal/Polymer Spinal System, Fusion - Product Code NQP
Product DTO" Implant
Code Information REF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965,
Recalling Firm/
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
FDA Determined
Cause 2
Action Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQP and Original Applicant = ZIMMER SPINE, INC