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U.S. Department of Health and Human Services

Class 2 Device Recall Plus Orthopedics

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  Class 2 Device Recall Plus Orthopedics see related information
Date Initiated by Firm April 17, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on December 03, 2003
Recall Number Z-0017-04
Recall Event ID 26326
510(K)Number K000666  
Product TC-PLUS Solution Tibial Component-- Symmetric
Code Information Lot 0211.13.4553
Recalling Firm/
Manufacturer		 Plus Endoprothetik AG
Erlenstrasse 4b
Rotkreuz Switzerland
For Additional Information Contact Niel Delaney
888-741-7587
Manufacturer Reason
for Recall		 Labeling/packaging mix-up.
FDA Determined
Cause 2		 Other
Action Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.
Quantity in Commerce 15
Distribution TX, CA, VA, ID, NY, UT, FL
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 = and Original Applicant = PLUS ORTHOPEDICS
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