Stanmore Implants Worldwide Ltd. FDA Inspection Record
Stanmore Implants Worldwide Ltd. is an FDA-inspected facility (FEI 3004105610) located in Borehamwood, GB. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Feb 2, 2023: No Action Indicated (NAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Jul 31, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 26, 2014
- Recalls as the recalling firm
- 4, latest Jul 4, 2017
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 2, 2023 | No Action Indicated (NAI) | No citations listed |
| Jul 31, 2014 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 4, 2017 | Class II | Z-3104-2017 | JTS External Drive Unit
JTS Distal Femoral Extendible Implant Femur is intended for the… Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in… |
| Dec 7, 2016 | Class II | Z-0820-2017 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short
The… and 4 more products The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been… |
| May 31, 2016 | Class II | Z-2553-2016 | METS SMILES Total Knee Replacement The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus… |
| Apr 12, 2016 | Class II | Z-1623-2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN… Incorrect component used to manufacture distal femoral replacement. |
FDA record score
2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-3104-2017, this FEI as the recalling firm | Jul 4, 2017 | 4 x 0.25 | 1 |
| Class II recall Z-0820-2017, this FEI as the recalling firm | Dec 7, 2016 | 4 x 0.25 | 1 |
| Class II recall Z-2553-2016, this FEI as the recalling firm | May 31, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1623-2016, this FEI as the recalling firm | Apr 12, 2016 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Nov 26, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jul 31, 2014 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
Reviewing Stanmore Implants Worldwide Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Stanmore Implants Worldwide Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Facility details
- Company
- Stanmore Implants Worldwide Ltd.
- Location
- Borehamwood (GB)
- Source
- inspections