| Class 2 Device Recall EVOLUTION MP TIBIAL BASE, REF ETPKN8SR | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = JWH
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