METS SMILES Total Knee Replacement — Class II medical device recall Z-2553-2016
Terminated recall by Stanmore Implants Worldwide Ltd., reported 2016-08-24, distributed in AL, MS, TX. The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral K
| Recall number | Z-2553-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanmore Implants Worldwide Ltd., Borehamwood, N/A, United Kingdom |
| Recall initiated | 2016-05-31 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-03-02 |
| Distributed | AL, MS, TX |
| Quantity | 3 units |
| Lot numbers | B4311, B5470 |
| Model numbers | MKFP/STD10, MKFP/STD5 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2553-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.