FDA-Device2016-08-24Class II
METS SMILES Total Knee Replacement
Stanmore Implants Worldwide Ltd.
Hazard
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.
Sold states
Directly distributed to TX, further distributed to AL and MS
Affected count
3 units
Manufactured in
210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, United Kingdom
Products
METS SMILES Total Knee Replacement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2016Don't want to check this manually?
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