Z-2553-2016 Class II Terminated
FDA device recall Z-2553-2016 was initiated by Stanmore Implants Worldwide Ltd. on May 31, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2017). Affected quantity: 3 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 24, 2016
- Initiation Date
- May 31, 2016
- Termination Date
- Mar 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2553-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026