|
Class 2 Device Recall P.F.C. |
 |
Date Initiated by Firm |
May 26, 2005 |
Date Posted |
August 12, 2005 |
Recall Status1 |
Terminated 3 on December 02, 2005 |
Recall Number |
Z-1225-05 |
Recall Event ID |
32192 |
PMA Number |
P830055S084 |
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
|
Product |
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 30.0 mm; Ref 96-0547. |
Code Information |
Lot 86493A. |
Recalling Firm/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
|
For Additional Information Contact |
800-366-8143
|
Manufacturer Reason for Recall |
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
|
FDA Determined Cause 2 |
Other |
Quantity in Commerce |
12 |
Distribution |
Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela. |
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.
|
PMA Database |
PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.
|
|
|
|