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/ 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 |
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = KRO and Original Applicant = STANMORE IMPLANTS WORLDWIDE LTD
|