| 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-1207-05 |
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 2.5, 12.5 mm; Ref 96-0521. |
Code Information |
Lot 84118A. |
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 | 11 |
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 |
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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.
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PMA Database | PMAs with Product Code = NJL
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