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 Triathlon

  • 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 Triathlon see related information
Date Initiated by Firm December 04, 2006
Date Posted February 08, 2007
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0400-2007
Recall Event ID 37024
510(K)Number K051146  
Product Classification knee prosthesis component - Product Code JWH
Product Triathlon X3 CR Tibial Bearing Insert
Size #7 - 11MM
Ref # 5530-G-711
2011-09

Howmedica Osteonics Corp.
Code Information Ref 5330-G-711 Lot G9XF7  LAF978
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall		 A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
FDA Determined
Cause 2		 Other
Action Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
Quantity in Commerce 24 units
Distribution Nationwide and Canada.
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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
-
-