Stanmore Implants Worldwide Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3104-2017 | Class II | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replaceme | July 4, 2017 |
| Z-0822-2017 | Class II | Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a | December 7, 2016 |
| Z-0823-2017 | Class II | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Fe | December 7, 2016 |
| Z-0824-2017 | Class II | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated | December 7, 2016 |
| Z-0821-2017 | Class II | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component | December 7, 2016 |
| Z-0820-2017 | Class II | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a | December 7, 2016 |
| Z-2553-2016 | Class II | METS SMILES Total Knee Replacement | May 31, 2016 |
| Z-1623-2016 | Class II | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 | April 12, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | January 20, 2015 |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | January 22, 2014 |
| K121765 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | January 11, 2013 |
| K121056 | METS MODULAR PROXIMAL FEMUR | September 20, 2012 |
| K121029 | METS MODULAR DISTAL FEMUR | September 19, 2012 |
| K121055 | METS MODULAR TOTAL FEMUR | September 19, 2012 |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | September 5, 2012 |
| K092138 | JTS EXTENDEABLE IMPLANT | March 22, 2011 |