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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 August 01, 2003
Date Posted November 13, 2003
Recall Status1 Terminated 3 on December 12, 2004
Recall Number Z-0107-04
Recall Event ID 27053
Product Classification Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
Product 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant.

Part of the ''RT/RT Modular'' total knee replacement.
Code Information No code information applies.
Recalling Firm/
Manufacturer		 Plus Orthopedics
6055 Lusk Blvd
San Diego CA 92121
For Additional Information Contact Niel Delaney
888-741-7587 Ext. 2511
Manufacturer Reason
for Recall		 Plastic insert over articular surface of knee joint replacement may become dislodged.
FDA Determined
Cause 2		 Other
Action Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
Quantity in Commerce 35
Distribution AZ, ID, TX CTdistributors.
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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