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Recall Observatory FDA recall evidence

Device product

METS SMILES Total Knee Replacement

Z-2553-2016

May 31, 2016

Class II

Product summary

Firm
Stanmore Implants Worldwide Ltd.
Event
Event 74403
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2553-2016

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.