Stanmore Implants Worldwide Ltd.
Stanmore Implants Worldwide Ltd. has 4 FDA enforcement events on this register (8 product records) between 2016 and 2017: 4 device; the busiest year was 2016 with 3.
0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 4 Jul 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. | Device | Class II | 1 | Terminated |
| 7 Dec 2016 | 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 | Device | Class II | 5 | Terminated |
| 31 May 2016 | METS SMILES Total Knee Replacement | Device | Class II | 1 | Terminated |
| 12 Apr 2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Stanmore Implants Worldwide Ltd. had?
4 enforcement events (8 product records) on this register, 2016–2017: 4 device.
Are any Stanmore Implants Worldwide Ltd. recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Stanmore Implants Worldwide Ltd. recalls?
4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.