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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Base Plates

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  Class 2 Device Recall Tibial Base Plates see related information
Date Initiated by Firm June 21, 2004
Date Posted December 14, 2004
Recall Status1 Terminated 3 on February 15, 2006
Recall Number Z-0305-05
Recall Event ID 29816
510(K)Number K912735  
Product Classification Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
Product Tibial Base Plates
Code Information Tibial Base Plates 726100, 726101, 727100, 727101, 726202, 726203, 727202, 727203, 726304, 726305, 727304, 727305 
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact R. Gordon Howe
901-399-5563
Manufacturer Reason
for Recall		 The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
FDA Determined
Cause 2		 Other
Action Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
Quantity in Commerce 11,339 units were distributed
Distribution Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.
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 = KRO and Original Applicant = SMITH & NEPHEW RICHARDS, INC.
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