| Date Initiated by Firm | December 22, 2003 |
|---|
| Date Posted | August 24, 2004 |
|---|
| Recall Status1 |
Terminated 3 on September 23, 2004 |
| Recall Number | Z-1369-04 |
|---|
| Recall Event ID |
29314 |
| 510(K)Number | K952830 |
|---|
| Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
| Product | P.F.C. Knee System 7
Fluted Femoral Stem 18mmX125mm
REF 96-1703 |
|---|
| Code Information |
Lot Number: 226436R |
Recalling Firm/
Manufacturer |
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
|
| For Additional Information Contact | Rick Sedlatschek
574-372-7322 |
|---|
Manufacturer Reason
for Recall | The collar was incorrectly etched for the R (right) and L (Left) orientation |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Depuy notified distributors at the various territories via verbal contact on 12/23/2003 |
|---|
| Quantity in Commerce | 1 unit |
|---|
| Distribution | NY |
|---|
| 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
|
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