Recall Z-2553-2016— Stanmore Implants Worldwide Ltd.
Class II · Terminated
Class II FDA medical device recall by Stanmore Implants Worldwide Ltd., initiated 2016-05-31, terminated 2017-03-02. It names one FDA 510(k) clearance: K120992. Product: METS SMILES Total Knee Replacement. 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..
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-31
- Terminated
- 2017-03-02
- Firm location
- Borehamwood, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.