Z-2553-2016Class II

METS SMILES Total Knee Replacement

Name: Z-2553-2016 METS SMILES Total Knee Replacement
Creator: Stanmore Implants Worldwide Ltd.
Published: 2016-05-31
License: https://open.fda.gov/license/

Stanmore Implants Worldwide, Ltd. / initiated 2016-05-31 / Terminated / root cause: design

FDA source

Stanmore Implants Worldwide Ltd. began a recall of METS SMILES Total Knee Replacement on 2016-05-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2553-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Posted: 2016-08-17
Terminated: 2017-03-02
Recalling firm: Stanmore Implants Worldwide, Ltd.
Product: METS SMILES Total Knee Replacement
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2553-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2553-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

Product code KRO

K120992Class IIMets Smiles Total Knee ReplacementStanmore Implants Worldwide , Ltd. / cleared 2012-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)