Stanmore Implants Worldwide Ltd.: Medical Device Recall in 2016 - (Recall #: Z-2553-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

METS SMILES Total Knee Replacement

Product Classification:

Class II

Date Initiated: May 31, 2016

Date Posted: August 24, 2016

Recall Number: Z-2553-2016

Event ID: 74403

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470

Distribution Pattern:

Directly distributed to TX, further distributed to AL and MS

Voluntary or Mandated:

Voluntary: Firm initiated