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
|