Stanmore Implants Worldwide Ltd. FDA Record
- Latest inspection NAI · Feb 2, 2023
- Last warning letter 2014
Stanmore Implants Worldwide Ltd. has 8 FDA recalls, 2 inspections, 8 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Stanmore Implants Worldwide Ltd., the most recent on Nov 26, 2014.
- Latest recall
- Z-3104-2017 · Class II · Jul 4, 2017
- Latest inspection
- Feb 2, 2023 · NAI
- Latest 510(k)
- Jan 20, 2015
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 8 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 8 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Stanmore Implants Worldwide Ltd.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 1 | 0 |
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Stanmore Implants Worldwide Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 26, 2014 · Record page |
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… | Jul 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… | Dec 7, 2016 |
| Z-0823-2017 | Class II | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated… | Dec 7, 2016 |
| Z-0824-2017 | Class II | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated… | Dec 7, 2016 |
| Z-0821-2017 | Class II | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component… | Dec 7, 2016 |
| Z-0820-2017 | Class II | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a… | Dec 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 | Apr 12, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 2, 2023 | Borehamwood, United Kingdom | Devices | No Action Indicated (NAI) | 3004105610 |
| Jul 31, 2014 | Borehamwood, United Kingdom | Devices | Official Action Indicated (OAI) | 3004105610 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Stanmore Implants Worldwide Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004105610 | Borehamwood, United Kingdom | 2 | Feb 2, 2023 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | Jan 20, 2015 |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | Jan 22, 2014 |
| K121765 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | Jan 11, 2013 |
| K121056 | METS MODULAR PROXIMAL FEMUR | Sep 20, 2012 |
| K121029 | METS MODULAR DISTAL FEMUR | Sep 19, 2012 |
| K121055 | METS MODULAR TOTAL FEMUR | Sep 19, 2012 |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | Sep 5, 2012 |
| K092138 | JTS EXTENDEABLE IMPLANT | Mar 22, 2011 |
Stanmore Implants Worldwide Ltd. and the FDA: common questions
Has Stanmore Implants Worldwide Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Stanmore Implants Worldwide Ltd.. The most recent is dated Nov 26, 2014.
Has Stanmore Implants Worldwide Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Stanmore Implants Worldwide Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stanmore Implants Worldwide Ltd.?
The most recent FDA inspection on file ended Feb 2, 2023 at Borehamwood, United Kingdom and was classified NAI. FDA has 2 inspections of Stanmore Implants Worldwide Ltd. on file, 1 of them classified OAI (official action indicated).
Has Stanmore Implants Worldwide Ltd. had an FDA recall?
Yes. Stanmore Implants Worldwide Ltd. has 8 FDA recalls on record. The most recent started Jul 4, 2017.
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