Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Stanmore Implants Worldwide with 8 510(k) clearances, 8 device recalls and 1 warning letter. The most recent is a warning letter dated May 3, 2019: Warning letter: Medical Devices.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 3, 2019 | Warning letter: Medical DevicesCDRH | Warning letters |
| Jul 4, 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the Class II · Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect or | Device recalls |
| Dec 7, 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended Class II · The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging con | Device recalls |
| Dec 7, 2016 | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA CClass II · The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging con | Device recalls |
| Dec 7, 2016 | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF CoClass II · The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging con | Device recalls |
| Dec 7, 2016 | 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 replacClass II · The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging con | Device recalls |
| Dec 7, 2016 | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component MClass II · The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging con | Device recalls |
| May 31, 2016 | METS SMILES Total Knee ReplacementClass II · The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating | Device recalls |
| Apr 12, 2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960Class II · Incorrect component used to manufacture distal femoral replacement. | Device recalls |
| Jan 20, 2015 | PATIENT SPECIFIC DISTAL FEMORALK140898 · KRO | 510(k) clearances |
| Jan 22, 2014 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANTK133152 · KRO | 510(k) clearances |
| Jan 11, 2013 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA)K121765 · OLO | 510(k) clearances |
| Sep 20, 2012 | METS MODULAR PROXIMAL FEMURK121056 · JDI | 510(k) clearances |
| Sep 19, 2012 | METS MODULAR DISTAL FEMURK121029 · KRO | 510(k) clearances |
| Sep 19, 2012 | METS MODULAR TOTAL FEMURK121055 · JDI | 510(k) clearances |
| Sep 5, 2012 | METS SMILES TOTAL KNEE REPLACEMENTK120992 · KRO | 510(k) clearances |
| Mar 22, 2011 | JTS EXTENDEABLE IMPLANTK092138 · KRO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
