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.
Other recalls by Stanmore Implants Worldwide
- JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the di…
FDA Device · Class II · 2017-09-13 · Stanmore Implants Worldwide - Tibial Component Fixed Hinge Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - DF Coated Integral Shaft & Stem 15x30x38
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Shaft L=120mm
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Integral Shaft & Stem 15x27 HA Coated
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
All Stanmore Implants Worldwide recalls
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.