METS SMILES Total Knee Replacement
FDA Recall Z-2553-2016 · Posted 2016-08-17
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Recalling FirmStanmore Implants Worldwide Ltd.
Recall StatusTerminated
Product CodeKRO
Date Initiated2016-05-31
Date Terminated2017-03-02
Product Quantity3 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Directly distributed to TX, further distributed to AL and MS
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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