FDA establishment 3004105610, Borehamwood, United Kingdom. Part of Stanmore Implants Worldwide's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 2, 2023 | Devices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Jul 31, 2014 | Devices · Postmarket Assurance: Devices | None posted | Official Action Indicated (OAI) |
| JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of…Device · Z-3104-2017 | Class II | Jul 4, 2017 |
| Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component…Device · Z-0820-2017 · 5 products | Class II | Dec 7, 2016 |
| METS SMILES Total Knee ReplacementDevice · Z-2553-2016 | Class II | May 31, 2016 |
| Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960Device · Z-1623-2016 | Class II | Apr 12, 2016 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Borehamwood, United Kingdom. Part of