Stanmore Implants Worldwide , Ltd.
Stanmore Implants Worldwide , Ltd. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2015, with 8 FDA device recalls on record.
Top product codes for Stanmore Implants Worldwide , Ltd.
FDA recalls by Stanmore Implants Worldwide , Ltd.
- Z-3104-2017 — JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
- Z-0820-2017 — Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Z-0822-2017 — Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Z-0823-2017 — Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Z-0824-2017 — DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Z-0821-2017 — Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Z-2553-2016 — METS SMILES Total Knee Replacement
- Z-1623-2016 — Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stanmore Implants Worldwide , Ltd.
- K140898 — PATIENT SPECIFIC DISTAL FEMORAL
- K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
- K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
- K121056 — METS MODULAR PROXIMAL FEMUR
- K121029 — METS MODULAR DISTAL FEMUR
- K121055 — METS MODULAR TOTAL FEMUR
- K120992 — METS SMILES TOTAL KNEE REPLACEMENT
- K092138 — JTS EXTENDEABLE IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.