Z-2553-2016 Class II Terminated

Recalled by Stanmore Implants Worldwide Ltd. — Borehamwood, N/A

Recall Details

Product Type
Devices
Report Date
August 24, 2016
Initiation Date
May 31, 2016
Termination Date
March 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

METS SMILES Total Knee Replacement

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.

Distribution Pattern

Directly distributed to TX, further distributed to AL and MS

Code Information

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