| 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-1186-05 |
Recall Event ID |
32192 |
510(K)Number | K033272 |
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product | Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 12.5 mm; Ref 1581-24-012. |
Code Information |
Lots Y45K44, Y45K64 and Y45K84. |
Recalling Firm/ Manufacturer |
Depuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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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 | 18 |
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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510(K) Database | 510(K)s with Product Code = JWH
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