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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 Replacementsee related information
Date Initiated by FirmMay 31, 2016
Date PostedAugust 17, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall NumberZ-2553-2016
Recall Event ID 74403
510(K)NumberK120992 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductMETS SMILES Total Knee Replacement
Code Information Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
FEI Number 3004105610
Recalling Firm/
Manufacturer		 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
ActionThe 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 Commerce3 units
DistributionDirectly distributed to TX, further distributed to AL and MS
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRO
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