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U.S. Department of Health and Human Services

Class 2 Device Recall METS SMILES Total Knee Replacement

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  Class 2 Device Recall METS SMILES Total Knee Replacement see related information
Date Initiated by Firm May 31, 2016
Date Posted August 17, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall Number Z-2553-2016
Recall Event ID 74403
510(K)Number K120992  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product METS SMILES Total Knee Replacement
Code Information Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
Recalling Firm/
Stanmore Implants Worldwide Ltd.
210 Centennial Avenue Centennial Park
Centennial Park
Borehamwood United Kingdom
Manufacturer Reason
for Recall
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
FDA Determined
Cause 2
Device Design
Action The recalling firm sent recall notification letters to their consignees on 05/31/2016. Follow up communciation was sent out on 7/26/2016 after a technical and medical assessment was completed.
Quantity in Commerce 3 units
Distribution Directly distributed to TX, further distributed to AL and MS
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 = STANMORE IMPLANTS WORLDWIDE LTD