METS SMILES Total Knee Replacement recall
METS SMILES Total Knee Replacement
Why was METS SMILES Total Knee Replacement 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
- Product
- METS SMILES Total Knee Replacement
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Quantity
- 3 units
- Distribution
- Directly distributed to TX, further distributed to AL and MS
- Recall date
- August 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)