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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 09, 2002
Date Posted November 27, 2003
Recall Status1 Terminated 3 on December 30, 2003
Recall Number Z-0170-04
Recall Event ID 25007
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
Code Information Lot 0006.13.2635
Recalling Firm/
Manufacturer		 Plus Orthopedics
6055 Lusk Blvd
San Diego CA 92121
For Additional Information Contact Neil Delaney
888-741-7587 Ext. 2511
Manufacturer Reason
for Recall		 Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
FDA Determined
Cause 2		 Other
Action Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
Quantity in Commerce 5
Distribution TX,
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.
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