Stanmore METS SMILES Total Knee Replacement Recall for Fit Issues
Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical implant where components may not fit correctly, posing a risk of harm during or after implantation, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 3 units of the METS SMILES Total Knee Replacement. The recall involves catalogue numbers mkfp/Std5 and mkfp/Std10, with batch numbers B4311 and B5470.
The manufacturer identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component. This defect means the plates may not sit flush upon the Femoral Knee component prior to implantation.
The affected units were directly distributed to Texas and further distributed to Alabama and Mississippi. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- METS SMILES Total Knee Replacement
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
Distribution
Related recalls
Same manufacturer · Stanmore Implants Worldwide Ltd.
See all →- HighStanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
FDA (Devices) · 2017-09-13
- ModerateStanmore Implants Recalls Punctured Femoral Shaft Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls Tibial Components Due to Packaging Puncture
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls Punctured Femoral Stem Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls DF Coated Integral Shaft and Stem Components
FDA (Devices) · 2016-12-28
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Similar recalls
- ModerateStanmore Implants Recalls Punctured Femoral Shaft Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls DF Coated Integral Shaft and Stem Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls Punctured Femoral Stem Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls Tibial Components Due to Packaging Puncture
FDA (Devices) · 2016-12-28
- HighStanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
FDA (Devices) · 2017-09-13
- HighStanmore Distal Femoral Replacement Recalled for Incorrect Component
FDA (Devices) · 2016-05-18