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

Class 2 Device Recall Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,

  • 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 Gender Solutions Natural Knee Flex System, Prolong Articular Surface, see related information
Date Posted November 13, 2009
Recall Status1 Terminated on May 16, 2011
Recall Number Z-0202-2010
Recall Event ID 53399
510(K)Number K070214 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code JWH
Product Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-16.

The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
Code Information Lots 60943101, 60964477, 60971773, 60971774, 60971776, 60971782, 60988217, 60992916, 60992917, 60992918, 61001541, 61005446, 61017689, 61036337, 61036364, 61051466, 61058610, 61069405, 61075252, 61085869, 61091190, 61096346, 61106547 and 61157808.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
FDA Determined
Cause 2
Action An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 26,404 of all products
Distribution Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
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 = JWH and Original Applicant = ZIMMER, INC.