FDA Device recall Z-2553-2016
METS SMILES Total Knee Replacement
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of METS SMILES Total Knee Replacement by Stanmore Implants Worldwide, citing 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 compone….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2553-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-31 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stanmore Implants Worldwide |
| Distribution | AL, MS, TX |
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.
Identifiers
| code_info | Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2553-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.