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U.S. Department of Health and Human Services

Class 2 Device Recall EVOLUTION MP TIBIAL BASE, REF ETPKN8SR

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  Class 2 Device Recall EVOLUTION MP TIBIAL BASE, REF ETPKN8SR see related information
Date Initiated by Firm February 02, 2015
Date Posted March 06, 2015
Recall Status1 Terminated 3 on March 19, 2015
Recall Number Z-1249-2015
Recall Event ID 70477
510(K)Number K093552  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Code Information Lot Numbers: 1560140, 15601401568897, 15601401570896
Recalling Firm/
Manufacturer		 Microport Orthopedics INC.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Cathy A.M. Park
901-867-4324
Manufacturer Reason
for Recall		 Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
FDA Determined
Cause 2		 Device Design
Action MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions were instructed to contact MPO's Customer Experience Department at 1-866-872-0211. For questions regarding this recall call 901-867-4324.
Quantity in Commerce 17 units
Distribution Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
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 and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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