Reported Aug 24, 2016 · Terminated

METS SMILES Total Knee Replacement

Stanmore Implants Worldwide Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stanmore Implants Worldwide Ltd. · 210 Centennial Avenue Centennial Park · Borehamwood, N/A · N/A

Is this the product you have?

  • METS SMILES Total Knee Replacement
Lot codes and dates
  • Catalogue Numbersmkfp/Std5
  • and mkfp/Std10 Batch NumbersB4311 and B5470
Amount recalled
3 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 2, 2017 · Data as of Sep 19, 5:20 PM UTC

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